FDA Recall of ReliOn Insulin Syringes

Amanda Wick

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The U.S. Food and Drug Administration (FDA) is recalling several thousand mislabeled ReliOn single use, disposable, hypodermic, insulin syringes. The ReliOn insulin syringes involved in the recall are labeled ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin, and are from Lot Number 813900. Approximately 471,000 syringes are subject to this recall.

The recalled syringes were sold at Wal-Mart and Sam’s Club stores from August 1, 2008 through October 8, 2008. Consumers who purchased syringes from either of these stores may return the product to any store location and will be provided with a replacement product.

According to the FDA, some syringes labeled for U-40 insulin became mixed with syringes labeled for U-100, all of which were then labeled for use with U-100 insulin during the packing process. This means that the use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death

Tyco HealthCare Group, the manufacturer of the ReliOn syringes, issued a voluntary recall on October 9, 2008 which asked retailers to remove the products from shelves and place them in quarantine. The recall announcement was also posted on Wal-Mart’s door and letters were sent to consumers.

The FDA urges consumers to carefully check their syringe packages carefully for ReliOn syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900. Consumers who suspect they may have the product can contact Tyco HealthCare Group (Covidien) at 866-780-5436 or may visit their website at www.relion.com/recall.

Consumers may also report any side effects that result from using the recall product to the FDA’s MedWatch program via phone, fax, mail, or internet.

FDA MedWatch Contact Information

Phone: (800) FDA-1088

Fax: (800) FDA-0178

Mailing Address: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

Internet: www.fda.gov/MedWatch/report.htm