The U.S. Food and Drug Administration has issued an alert for healthcare professionals and patients that a lot of ReliOn insulin syringes sold at Wal-Mart and Sam’s Club’s may be dangerously mislabeled. The manufacturer of the syringes, Tyco Healthcare Group LP, has voluntarily recalled the needles.
Diabetes patients who use the recalled syringes may inadvertently receive an overdose of up to 2.5 times the intended dose. Possible complications could include hypoglycemia and other serious side effects and death.
The warning is especially urgent for parents or others caring for children with diabetes.
The product consists of sterile, single-use, disposable, hypodermic needles attached to a syringe barrel and plunger rod. The recall applies only to sets of needles with the lot number 813900 and label “ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin.”
The needles are distributed by Can-Am Care Corp and sold only at Wal-Mart and Sam’s Clubs with the ReliOn brand name.
Wal-Mart requests that customers who purchased needles with the 813900 lot number return them to the Wal-Mart or Sam’s pharmacy where they were purchased for a replacement.
Additionally, consumers and healthcare professionals who have or suspect they have the mislabeled syringes may contact ReliOn (also known as Covidien) at 866-780-5436 or go to www.reion/recall for more information and assistance.
The error occurred during the packaging process when syringes for U-40 insulin were mixed with U-100 insulin syringes and then packaged individually and boxed in units of 100 as “U-100 insulin.”
The recalled lot affects 4,710 boxes / 471,000 individual syringes. Wal-Mart has sent more than 16,500 letters to customers notifying them of the recall.
One adverse event resulting from use of these needles has been reported to the manufacturer.