• Warning for Counterfeit Insulin Pens

    Health Care Inspectorate Warns of Counterfeit Insulin Needles

    Products counterfeited: Insulin needles Lot numbers: 08J02S
    Countries known affected: Netherlands, UK, Poland Investigating agency contact: Inspectie Voor de Gezondheidszorg
    Manufacturers information: Novo Nordisk Posted on/updated: July 2009

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    The Netherlands Health Care Inspectorate [Inspectie voor de Gezondheidszorg (IGZ)] has issued a public warning following the discovery of counterfeit needles for insulin delivery systems (insulin pens). Use of these needles could present a health risk. It is known that some 200,000 counterfeit needles have been introduced to the Netherlands, of which 30,000 remain unaccounted for and may still be in circulation.

    A Dutch company purchased 2,000 packs of needles (with 100 needles in each pack) from a wholesaler in Malaysia. The wholesaler claims that the needles derive from Iran. The supply line cannot be traced beyond this point. The Health Care Inspectorate continues to investigate the matter.

    Some 200,000 counterfeit needles were released onto the Dutch market, a further 500,000 in the United Kingdom and over 1.3 million in Poland. A total of over two million counterfeit needles have therefore found their way into the regular European distribution channels.

    Novo Nordisk B.V., the licensed distributor of genuine NovoFine® insulin needles in the Netherlands, received a patient complaint stating that a recently purchased needle did not fit properly onto the insulin delivery pen. Novo Nordisk submitted a large quantity of needles to its parent company in Denmark for inspection. It was determined that the needles were counterfeit, whereupon the manufacturer reported to matter to the appropriate authority, the Netherlands Health Care Inspectorate.

    The Inspectorate advises any users who are unsure of the origins of their needles to contact their pharmacist or supplier. All information about the current situation can be found on the manufacturer’s website at www.novonordisk.nl.

    The Health Care Inspectorate consulted the Royal Dutch Association for the Advancement of Pharmacy (KNMP) prior to issuing this press release. The Association informed its members of the situation on Friday, June 19.


    How Can Users Identify a Counterfeit Needle?

    • Packaging information in English: genuine needles distributed in the Netherlands have packaging information in Dutch.
    • The packaging of the counterfeit needles has no barcode.
    • Being of inferior quality, the counterfeit needles may not fit the screw thread of the insulin delivery pen properly.
    • Counterfeit needles found thus far have the Batch/Lot number 08J02S and an expiry date of 08/2013.
    • Traces of transparent adhesive may be apparent where the needle is affixed to the plastic holder.
    • The packaging may bear a sticker / adhesive label, which is unusual.
    • On the packaging of the counterfeit items, the line below the “CE” logo is missing.

    Risks

    Use of the counterfeit needles presents a number of risks. The needle could break off during use. The needle may not fit onto the insulin delivery pen properly, whereupon insulin is not administered in the correct dosage. It is not known whether the counterfeit needles have been thoroughly sterilised: they could cause discomfort, skin irritation or infections.

    The Netherlands Health Care Inspectorate has informed the relevant authorities in all European member states and is also to contact the World Health Organization (WHO).

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