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Manufacturer Recalls Millions of Insulin Syringes

Accusure Needles May Detach During Use

By News Staff
10/28/2009

Qualitest Pharmaceuticals Inc. is recalling millions of its Accusure insulin syringes after receiving complaints that some needles have detached from the syringes.
Product Recall
The Huntsville, Ala.-based company initially recalled two lots of syringes distributed in 2007 and 2008, but the recall was expanded on Oct. 27 to include all Accusure insulin syringes distributed from January 2002 to October 2009.

The company said in a press release posted on the FDA Web site that the syringes were distributed nationwide to wholesale and retail pharmacies. Affected products have the following descriptions and national drug codes:
  • 28G 1/2cc, NDC 0603-6995-21;
  • 28G 1cc, NDC 0603-6996-21;
  • 29G 1/2cc NDC 0603-6997-21;
  • 29G 1cc, NDC 0603-6998-21;
  • 30G 1/2cc, NDC 0603-999-21;
  • 30G 1cc, NDC 0603-7000-21;
  • 31G 1/2cc, NDC 0603-7001-21; and
  • 31G 1cc, NDC 0603-7002-21.
The company has not received any reports of injuries. However, Qualitest said in its release that if a needle detaches from the syringe during use, it can become stuck in the vial, push back into the syringe or remain in the skin after injection.

Consumers who have Accusure insulin syringes should stop using them and contact Qualitest at (800) 444-4011 for reimbursement. The company said it is notifying customers who received the syringes and is arranging for the return of affected products.

As always, adverse reactions or quality problems may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.