Nationwide Recall of Insulin Syringe 1-cc, 28-Gauge 1/2-Inch 100’s

FDA Recalls the AccuSure Insulin Syringes made by Qualitest Pharmaceuticals, Inc. The U.S. Food and Drug Administration (FDA) and Qualitest Pharmaceuticals, Inc., have notified healthcare professionals and consumers via letter of a nationwide recall of all lots of 1-cc, 28 gauge 1/2-inch AccuSure insulin syringes (NDC 0603-6996-21, boxes of 100) distributed between October 2004 and June 2005.

The action is due to labeling errors on the inner wrap holding 10 individual syringes — some 1-cc syringes may be mislabeled as 1/2 cc. Although no injuries have been reported to date, the error could potentially lead to the administration of incorrect drug dosages, according to an alert sent today from MedWatch, the FDA’s safety information and adverse event reporting system.
Consumers are advised to refrain from using the affected syringes and contact the company to arrange for their return. Unused syringes may also be returned to the purchasing point. Additional information may be obtained by contacting the Qualitest Pharmaceuticals at 1-800-444-4011.