A lot of ReliOn sterile, single - use, disposable, hypodermic syringes with permanently-affixed hypodermic needles has been recalled by the FDA. The FDA has notified that the recall has been on the basis of mislabeling. During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin and packed in boxes use with U-100 insulin.

The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose leading hypoglycemia, serious health consequences, and even death. ReliOn distributed 4,710 boxes in the mislabeled lot to Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008. This means 471,000 individual syringes have been recalled due to the packaging mistake.

The affected lot number is 813900. Wal-Mart has requested all users of ReliOn 31-gauge, 1cc syringes labeled as 100 units for use with U-100 insulin from Lot Number
813900, to return them to their local Wal-Mart store or Sam's Club pharmacy. Customers have been assured of replacement product.

The company has voluntarily recalled this lot of syringes on Oct. 9, 2008. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.