October 28, 2009
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All Accusure insulin syringes distributed since 2002 recalled

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Qualitest Pharmaceuticals and the FDA have announced a voluntary recall of all Accusure insulin syringes, regardless of lot number, distributed from January 2002 to October 2009 to wholesale and retail pharmacies nationwide and in Puerto Rico.

In August, the company announced a voluntary nationwide recall of two lots of the syringes. In both cases, the company has said the syringes may contain needles that detach from the syringe. If detached during use, the needle can become stuck in the insulin vial, push back into the syringe or remain in the skin after injection.

The company issued the following descriptions and NDC numbers for the syringes affected by the recall:

  • 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.

Lot numbers are located on the white paper backing of each individual syringe. Consumers who have Accusure insulin syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement.

The company is notifying all customers who received these syringes and arranging for the return of any affected product. Health care professionals and patients are encouraged as always to report adverse reactions or quality problems with these syringes to the FDA’s MedWatch Adverse Event Reporting program.