Insulin Syringes Recalled over Mislabeling and Overdose Risk

The US Food and Drug Administration is alerting doctors and patients that Tyco Healthcare Group (Covidien) is recalling 4,710 boxes of insulin syringes – with 100 syringes in each box – that were sold at Wal-Mart and Sam’s Club from August 1, 2008 through October 8, 2008.

The syringes recall is due to possible mislabeling and overdose risk. Their use “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,” the FDA said in a statement.

The agency says some syringes labeled for use with U-40 insulin got packaged with syringes for U-100 insulin.

The recall applies to ReliOn Insulin Syringes (31 gauge 1 cc) from lot number 813900 having product identification number 38396-0403-02. The number can be found on the top panel upper right-hand corner of the syringe box. The FDA said the manufacturer has already received one adverse report related to a syringe from this lot.

A recall announcement was posted in Wal-Mart stores and Sam’s Clubs as well as on Wal-Mart website. Moreover, the company sent letters to more than 16,500 customers notifying them of the recall.

Anyone having the recalled product is invited to contact Covidien at 866-780-5436 or www.relion.com/recall for more information. Customers bringing it back will be provided with a replacement package.

Also, consumers may report any side effects resulting from using the recalled syringes to the FDA’s MedWatch program.