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FDA ANNOUNCES RECALL OF AccuSure INSULIN SYRINGE 1-cc, 28-Gauge 1/2-Inch 100’s

Jun 18, 2005 |

The 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, the error could potentially lead to the administration of incorrect drug dosages.

Consumers are advised to stop using the affected syringes immediately and contact the company to arrange for their return. Unused syringes may also be returned to the place of purchase.

Additional information may be obtained by contacting the Qualitest Pharmaceuticals at 1-800-444-4011. Adverse events related to the use of AccuSure insulin syringes should be reported to the FDA's MedWatch 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, MD 20852-9787.

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