Notificaciones De Seguridad De Campo acerca de Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S

Field Safety Notice

2009-04-02

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-insulin-pen-needles-novofine-needles-31g-0.25mm-x-6mm-lot-number-08j02s&id=0a8df825-9782-6eee-9b55-ff00008c97d0

The mhra in the united kingdom have issued a medical device alert (mda/2009/021) concerning counterfeit novofine 31g insulin pen needles, 0.25m x 6mm in circulation in the united kingdom.  it is highly unlikely that the counterfeit needles have been manufactured to the appropriate standards.  the insulin used including the pen injection device is not affected.   to date, there is no evidence that these counterfeit products have been placed on the irish market.  lot number 08j02s is the only affected lot number.  there is no genuine product on the irish market with the same lot number.    as a precautionary measure, the imb are requesting that consumers and pharmacies check the lot number on the protective tab for the needle and on the carton label for the affected lot number.    the imb are advising pharmacies to examine their stock and immediately cease sales of lot number 08j02s.    should consumers have any of the counterfeit needles, the imb advise consumers to return any affected product to their local pharmacy and those with health concerns should consult with their general practitioner.   please notify the imb immediately if you have any novofine needles 31g, 0.25m x 6mm, lot number 08j02s.   the imb will continue to monitor this issue closely along with our colleagues in the united kingdom.