Recall of Mislabeled ReliOn Insulin Syringes

Mislabeled insulin syringes can cause patients to get 2.5 times more insulin then expected. The FDA posted the following at their website on November 5 about some U-40 syringes being packaged as U-100 syringes. Most folks in the US are using U-100 insulin, and U-100 syringes, and may be completely unaware that in other parts of the world, insulin is produced in U-40 strength, and corresponding U-40 insulin syringes are used. If someone uses U-100 insulin with syringes labeled for U-40 insulin, there’s a mismatch, and a risk of getting 2.5 times as much insulin as expected.

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The recall applies to the following lot number and product information:
— Lot Number 813900

— ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.
These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam’s Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam’s Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

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

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