Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2017-205
public health warning against the purchase and use of the unregistered medical device product “stay fresh anion premium pantyliner”
the food and drug administration (fda) advises the public against the purchase and use of the unregistered medical device product stay fresh anion premium pantyliner:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device product has not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with fda. always check if the medical device product has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at ww2.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative stay fresh anion premium pantyliner until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2017-205.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2017-212
public health warning against the purchase and use of unregistered health related device (water purification device) “biocera alkaline antioxidant stick”
the food and drug administration (fda) advises the public against the purchase and use of the unregistered health related device product biocera alkaline antioxidant stick:
fda post-marketing surveillance (pms) activities have verified that the abovementioned health related device have not gone through the registration process of the agency and have not been issued the proper authorization in the form of certificate of health related device registration (chrdr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since unregistered health related device products have not gone through evaluation and testing process of the fda, the agency cannot guarantee their quality and safety. the consumption of such violative products may pose potential health hazards to the consuming public. health related device products especially water purification device/system should not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water.
in light of the above, the public is advised not to purchase the aforementioned violative products. moreover, the public is advised to be vigilant against health related device products that might not be duly registered with fda. always check if a health related device product has been registered with fda before purchasing it by making use of the embedded search feature of the fda website accessible at ww2.Fda.Gov.Ph.
all concerned establishments are warned not to distribute the above-identified violative health related device product until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
attachments:
fda advisory no. 2017-212.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2017-248
voluntary recall of ipsogen bcr-abl1 mbcr is-mmr kit and ipsogen bcr-abl1 mbcr rgq rt-pcr kit
all are hereby advised by the food and drug administration (fda) about the lots of the following research use only (ruo) ipsogen kits distributed by getz bros. philippines inc. 5th floor ortigas bldg. ortigas ave pasig city, philippines:
research use only (ruo) kit name
kit ref
kit lot
is-mmr calibrator mat
is-mmr calibrator lot
erroneous ncn assigned is-cal value for the is-mmr calibrator
corrected ncn assigned is-cal value for the is-mmr calibrator
ipsogen bcr-abl1 mbcr is-mmr kit
670713
95701390
1071927
95701327
0.081
0.124
95701403
95701513
95701655
95701524
95700448
95700957
0.094
0.143
95700450
95700997
95701174
95701664
95701806
0.092
0.140
95701896
95701897
95701974
ipsogen bcr-abl1 mbcr rgq rt-pcr kit
670913
95701191
1062899
95701222
0.1238
0.1848
95701413
95701532
95700425
95700842
0.1385
0.2057
the cited product are being voluntarily recalled by getz bros. philippines inc. because of the report issued by its main manufacturer in other country. according to the report, there is a labelling error in the is-cal value used in the calculation for the conversion of the qualitative results to the international standard on certain lots. this error has led to significant change in the molecular response reporting for is-mmr and rt-pcr kits. for the ipsogen bcr-abl1 mbcr is-mmr kit, the magnitude of error may induce a change from “inconclusive result” to “mmr” status or “no mmr” status to “inconclusive result.” for ipsogen bcr-abl1 mbcr rgq rt-pcr kit the magnitude of error may induce a change from “mr4” to “mr4.5”; “mmr” to “mr4”; and “no mmr” to “mmr.” thus, erroneous data might be obtained from these affected lots.
all consumers are advised not to purchase or use the affected product lots. distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use.
any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it.
.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2017-248.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2017-298
reiteration of fda advisory no. 2017-212 entitled “public health warning against the purchase and use of unregistered health related device (water purification device) biocera alkaline antioxidant stick, fda advisory no. 2014-032 entitled “false, deceptive and misleading claims and strategies to promote “izumi 5p antioxidant alkaline water ionizer” and fda advisory no. 2014-010 entitled “consumer warning against false, deceptive and misleading claims and promotional ploys on “alkaline water” and “oxygenated water”
the food and drug administration (fda) advises the public against the purchase and use water purification devices that allegedly produce water known as “alkaline”, “oxygenated”, “ionized”, “hydrogenated” and all claims that are therapeutic in nature as a ploy to promote and market water purification devices.
consumers are advised not to fall prey to these false, deceptive and misleading claims. therapeutic claims made on drinking water as a ploy to promote and market water must be substantiated through valid clinical trials.
fda observed proliferation of device products promoted and offered for sale or use of purification devices with claims stated above has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provisions of republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited. the products that did not undergo the evaluation process of the fda cannot guarantee its quality and safety.
all concerned establishments and/or entities are warned not to advertise, sell or distribute products with such claims until such have been issued by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that water purification device product is not sold or made available in their localities or areas of jurisdiction without proper authorization.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
or call the product research and development division - center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2017-298.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2017-329
voluntary recall of av-set b dt inf-e blood tubing system with dvr no. 8574 (article no. ap16641)
all are hereby advised by the food and drug administration (fda) about the voluntary recall of the following batches of av-set b dt inf-e blood tubing system (see figures 1 and 2) with dvr no. 8574. the said products were imported and distributed by fresenius medical care philippines, inc. with office address at chino roces avenue, makati city.
product name: av-set b dt inf-e blood tubing system
certificate of registration number: dvr-8574
article no. : ap16641
batch number
batch number
batch number
1
ybc132
18
ygc142
35
ybc144
2
ycc092
19
ygc152
36
ybc153
3
ydc262
20
ybc181
37
ybc181
4
ydc271
21
ycc043a
38
ycc032
5
ydc282
22
ycc122
39
ycc043a
6
ydc301
23
ycc301
40
ycc081
7
yec013
24
ydc012
41
ycc092
8
yec031
25
ydc262
42
ycc122
9
yec053
26
ydc271
43
ydc011
10
yec294
27
ydc282
44
ydc262
11
yfc012
28
ydc301
45
ydc271
12
yfc023
29
yec013
46
ydc282
13
yfc091
30
yec031
47
ydc301
14
yfc103
31
yec053
48
yec013
15
yfc113
32
yec063
49
yec031
16
ygc102
33
yec294
50
yec053
17
ygc131
34
ybc132
*nothing follows*
the above-stated medical device products are being voluntary recalled by fresenius medical care philippines, inc. because small clamps located at pre-pump position of t connector and post-pump positions of arterial and venous chamber may not close properly and could in some cases lead to blood leakage during treatment.
distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product.
any suspected adverse reaction experienced from the use of the device but not limited to the lot stated above, should be reported immediately to fda at telephone number (02) 857-1900 local 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it.
.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2017-329.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-068
public health warning against the purchase and use of unregistered medical device products:
scalp vein set
medical supply co. disposable infusion set
cardinal care premium disposable syringes with mounted needle
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the following unregistered medical device products:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device products have not gone through the registration process of the agency and have not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device have not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at ww2.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-068.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-091
public health warning against the purchase and use of unregistered medical device the exergen thermometer
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device products:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product have not gone through the registration process of the agency and have not been issued with proper authorization in the form of certificate of product registration (cpr).Pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device have not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-091.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-093
public health warning against the purchase and use of unregistered lbf povidone-iodine pre pad as medical device product
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device products:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product have not gone through the registration process of the agency and have not been issued with proper authorization in the form of certificate of product registration (cpr).Pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device have not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-093.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-100
public health warning against the purchase and use of unregistered medical device sure-gel (acidulated phosphated fluoride)
the food and drug administration (fda) hereby advises the public against the purchase and use of the product sure-gel (acidulated phosphated fluoride) whose particular/details are provided below:
name of product
name of manufacturer/importer
and distributor
status of registration
sure-gel (acidulated phosphated fluoride)
not indicated
unregistered
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of certificate of product registration. pursuant to republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
in this regard, the public is hereby advised not to purchase and use the above-mentioned product and to be vigilant against the medical device products that are not registered with the fda.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold in any market.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
or call the product research and development division – center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-100.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-115
public health warning against the purchase and use of medical devices (condoms) that are unregistered and with expired certificate of product registration
the food and drug administration (fda) advises the public against the purchase and use of the following medical device products:
post-marketing surveillance activities conducted by the fda have verified that trojan latex condom - thin mince (see figure 1) has not gone through the registration process of the agency and has not been issued with certificate of product registration (cpr). furthermore, it was found out that the cpr of trojan latex condom - naked sensations fire & ice (see figure 2) was already expired.
pursuant to the provisions of republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited.
since the abovementioned products did not undergo the evaluation process of the fda, the agency cannot guarantee their quality and safety.
in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding cerificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agenies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research hotline 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-115.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-116
public health warning against the purchase and use of unregistered lubricant jelly as medical device product
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device products:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product have not gone through the registration process of the agency and have not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device have not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-116.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-120
public health warning against the purchase and use of the unregistered medical device product (indoplas infrared ear thermometer)
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device indoplas infrared ear thermometer:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device has not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
attachments:
fda advisory no. 2018-120.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-121
public health warning against the purchase and use of the unregistered medical device products (sure-guard disposable vinyl gloves and sure-guard disposable nitrile gloves)
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical devices sure-guard disposable vinyl gloves and sure-guard disposable nitrile gloves:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical devices have not gone through the registration process of the agency and have not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since these unregistered medical devices have not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative products may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical devices until such have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
attachments:
fda advisory no. 2018-121.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-122
public health warning against the purchase and use of unregistered medical device (unimex nasal oxygen cannula (pedia) with 7 feet crush resistant tubing)
the food and drug administration (fda) hereby advises all concerned healthcare professionals, establishments and general consuming public against the purchase and use of unimex nasal oxygen cannula (pedia) with 7 feet crush resistant tubing whose picture appears below:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provisions of republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited.
the abovementioned product did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its quality and safety.
in this regard, the public is hereby advised not to purchase the above-mentioned violative product and to be vigilant against the medical device products that are not registered with the fda.
distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said medical device product.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that the product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research hotline 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-122.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-130
public health warning against the purchase and use of the unregistered medical device product “sure-guard pregnancy test kit”
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical sure-guard pregnancy test kit:
food and drug administration (fda) post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has expired certificate of product registration (cpr) and there is no pending application for renewal. pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
attachments:
fda advisory no. 2018-130.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-149
public health warning against the purchase and use of unregistered in-vitro diagnostic medical devices (fujibio hiv test kit and diagnose pregnancy test kit)
the food and drug administration (fda) advises all concerned healthcare professionals and the public against the purchase and use of the following in-vitro diagnostic medical device products:
fda post-marketing surveillance activities have verified that fujibio hiv test kit (see figure 1) and diagnos pregnancy test kit (see figure 2) have not gone through the registration process of the agency and have not been issued with certificate of product registration (cpr).
pursuant to the provisions of republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited.
since the abovementioned products did not undergo the evaluation process of the fda, the agency cannot guarantee their quality and safety.
in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding cerificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agenies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call the center for device regulation, radiation health, and research at (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-149.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-150
public health warning against the purchase and use of the following unregistered medical devices:
generation guard intelliscan clinical forehead thermometer
feverwatchers clinical non-contact infrared thermometer
h.N.B forehead and ear infrared non-contac thermometer
the food and drug administration (fda) advises all concerned healthcare professionals and the public against the purchase and use of the following medical device products:
fda post-marketing surveillance activities have verified that generation guard intelliscan clinical forehead thermometer (see figure 1), feverwatchers clinical non-contact infrared thermometer (see figure 2) and n.H.N.B forehead and ear infrared non-contact thermometer (see figure 3) have not gone through the registration process of the agency and have not been issued with certificate of product registration (cpr).
pursuant to the provisions of republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited.
since the abovementioned products did not undergo the evaluation process of the fda, the agency cannot guarantee their quality and safety.
in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding cerificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agenies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call the center for device regulation, radiation health, and research at (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-150.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-158
lifting the advisory of cardinal care premium disposable syringes with mounted needle under fda advisory no. 2018-068, subject “public health warning against the purchase and use of the unregistered medical device products”
the food and drug administration (fda) informs the public that the advisory on the medical device product “cardinal care premium disposable syringes with mounted needle” under fda advisory no. 2018-068 dated 07 march 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations.
fda approved on the stickering of the correct registration no. (dvr-7937) on the blister pouch of the 9,544 pcs. recalled cardinal care premium disposable syringes with mounted needle with lot no. 170725 expiring on 24 july 2022.
the provisions of fda advisory no. 2018-068 indicating unregistered medical device products are still in effect.
the issuance of this advisory shall not in any manner preclude this office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
.
attachments:
fda advisory no. 2018-158.Pdf.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-163
public health warning against the purchase and use of unregistered medical device “smart solution all-in-one solution”
the food and drug administration (fda) hereby advises all concerned healthcare professionals, establishment and general consuming public against the purchase and use of smart solution all-in-one solution whose pictures appear below.
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provision of republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited.
the abovementioned product did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its quality and safety.
in this regard, the public is hereby advised not to purchase the above-mentioned violative product and to be vigilant against the medical device products that are not registered with fda.
distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said medical device product.
for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it.
. or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-163.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-164
public health warning against the purchase and use of unregistered medical device man-di brand adhesive bandages
the food and drug administration (fda) hereby advises the public against the purchase and use of the product man-di brand adhesive bandages whose particular/details are provided below:
name of product
name of manufacturer/importer
and distributor
status of registration
man-di brand adhesive bandages
not indicated
unregistered
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued the proper authorization in the form of certificate of product registration. pursuant to republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
in this regard, the public is hereby advised not to purchase and use the above-mentioned product and to be vigilant against the medical device products that are not registered with the fda.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold in any market.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
or call the product research and development division – center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-164.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-170
public health warning against the purchase and use of the unregistered medical device product (curad plastic bandage)
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device product curad plastic bandage:
fda post-marketing surveillance (pms) activities have verified that the above-mentioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device has not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device product until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
attachments:
fda advisory no. 2018-170.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-171
public health warning against the purchase and use of unregistered medical device products:
meisons surgical examination latex gloves non sterile
meisons surgical examination nitrile gloves
the food and drug administration (fda) hereby advises the general public and healthcare professionals against the purchase and use of the following medical device products:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of certificate of product registration. pursuant to republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
in this regard, the public is hereby advised not to purchase and use the above-mentioned products and to be vigilant against the medical device products that are not registered with the fda.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold in any market.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
or call the product research and development division – center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-171.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-176
public health warning against non-certified therapeutic claims on the advertisement and promotion of hydrogen water generator
the food and drug administration (fda) warns the public against non-certified therapeutic claims on the advertisement and promotion of hydrogen water generator:
among the unsubstantiated health claims used on the said product are as follows:
helps cure and fight wide range of diseases, boosts immune system;
anti-aging, anti-wrinkle;
act as therapeutic antioxidant;
helps prevent brain injuries, heart disease and age related memory loss;
improves concentration;
prevents cancer and diabetes;
strengthen immune system; and
enhance immune system of children
therapeutic claims made on drinking water must be substantiated through valid clinical trial. the above health claims used in the advertisement of the said product have not been validated and approved by the fda.
sale, distribution and advertisement of health products without prior approval from the fda is a violation of the provisions of republic act 9711 or the food and drug administration (fda) act of 2009.
the public is hereby advised not to fall prey to distributors and retailers of the said product and to be vigilant and observe precautionary measures in purchasing products with misleading and deceptive health claims.
for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call the center for device regulation, radiation health and research hotline at (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-176.Pdf.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-187
public health warning against the purchase and use of unregistered medical device “medicare antiseptic plastic strips with acrinol”
the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device medicare antiseptic plastic strips with acrinol which picture appears below:
fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited.
accordingly, since this unregistered medical device has not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public.
in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.
all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it.
, or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-187.Pdf.