What: More than two million counterfeit insulin needles were found in established European distribution channels.
When: July 1, 2009
Where: Netherlands, Poland and the United Kingdom
How: A Dutch company purchased insulin needles from a wholesaler in Malaysia, which claimed the needles came from Iran. The needles were subsequently distributed throughout the UK and Poland.
Who: Novo Nordisk BV; Netherlands Health Care Inspectorate
On March 27, 2009, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) reported the discovery of counterfeit NovoFine 31G insulin needles which are manufactured by Novo Nordisk.
On June 19, 2009, the Netherlands Health Care Inspectorate issued a public warning following the discovery of the same counterfeit insulin needles in the Dutch market. The discovery came after the manufacturer received a patient complaint that a recently purchased needle didn’t fit properly on the insulin pen.
The complaint led to the discovery of 200,000 counterfeit needles in the Dutch market; 500,000 in the United Kingdom; and more than 1.3 million in Poland. Thirty thousand counterfeit needles are still unaccounted for in the Netherlands and may be in circulation.
Thus far, the counterfeit needles have been identified as lot number 08J02S and having an expiry date of 08/2013.
In addition to improper fitting, the counterfeit needles share these characteristics:
- Missing barcode from the package
- Packaging information written in English rather than Dutch
- Missing line below the “CE” logo on the packaging
- Traces of transparent adhesive where the needle is affixed to the plastic holder
The dangers of using counterfeit insulin needles include breakage during use; incorrect administration of the necessary dosage; and discomfort, skin irritation or infection due to any improper sterilization or handling that may have occurred.
Information about this case can be found on the Novo Nordisk Netherlands site at www.novonordisk.nl.
Statement: “Counterfeit insulin needles removed from Dutch market,” Mediq. June 30, 2009.
“MEDIQ WARNS FOR COUNTERFEIT NOVO NORDISK INSULIN NEEDLES,” Bloomberg News. June 22, 2009.
Alert: Insulin pen needles: Labelled as Novo Nordisk Ltd Novofine® Needles 31G,” MHRA. March 27, 2009.