Product Liability

Insulin syringes recalled; may pose risk to patients

A type of syringe used to deliver insulin to patients with diabetes has been recalled by the manufacturer because they may pose a risk to patients, according to a notice issued by the Food and Drug Administration (FDA).

Qualitest Pharmaceuticals, Inc., is recalling some lots of its Accusure Insulin Syringes because the syringes in the specified lots have been found to have needles that can detach fro the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection.

The recall affects Accusure Insulin Syringes (1/2 cc – 31 G – short needle) with lot number 6JCB1 (Expiration 10.2010) – NDC 0603-7001-21. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies throughout the U.S. and Puerto Rico. Qualitest is also recalling Accusure Insulin Syringes (1 cc-31 G – short needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21, which was distributed between May 2007 and June 2008 to wholesalers and pharmacies throughout the U.S. and Puerto Rico. The lot numbers for these syringes can be found on the white paper backing of each individual syringe.

Consumers who have any of the recalled syringes should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instruction. Any adverse events associated with use of the syringes should be reported to the FDA’s MedWatch Adverse Event Reporting Program.