Accusure Insulin Syringe Recall Expanded

Emma Hitt, PhD


October 29, 2009

October 29, 2009 — Accusure insulin syringes (Qualitest Pharmaceuticals, Inc) distributed nationwide from January 2002 through October 2009 are being voluntary recalled because of the possibility of detachment of the needles from the syringes.

The current recall is an expansion of a recall made in August for syringes produced between January 2007 and June 2008 as a result of the manufacturer receiving a complaint about a syringe not included in the first recall.

According to Carole Ben-Maimon, MD, senior vice president of corporate strategy for the manufacturer, the recall affects about 250 million syringes, although she told Medscape Medical News that many of those syringes have already been used. "It is not clear how many are still in circulation," she said.

"If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection," according to a statement from MedWatch, the FDA's safety information and adverse event reporting program.

"All Accusure Insulin Syringes regardless of lot number are subject to this recall," a company press release states. Lot numbers are found on the white paper backing of each individual syringe, according to the US Food and Drug Administration report.

The distributed syringes are of the following descriptions and NDC numbers: 28 G, 1/2 cc, NDC 0603-6995-21; 28 G, 1 cc, NDC 0603-6996-21; 29 G, 1/2 cc, NDC 0603-6997-21; 29 G, 1 cc, NDC 0603-6998-21; 30 G, 1/2 cc, NDC 0603-999-21; 30 G, 1 cc, NDC 0603-7000-21; 31 G, 1/2 cc, NDC 0603-7001-21; and 31 G, 1 cc, NDC 0603-7002-21.

Patients should stop using the syringe and contact Qualitest at 1-800-444-4011 for product replacement instructions.

Adverse events related to use of Accusure insulin syringes should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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