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FDA reports insulin syringe recall
One lot of Relion insulin syringes has been recalled due to mislabeling that could lead to serious health consequences.
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The FDA announced that Covidien, formerly Tyco Healthcare, recalled one lot of Relion sterile, single-use, disposable, hypodermic syringes with affixed hypodermic needles due to possible mislabeling. Use of the product could lead to an overdose of as much as 2.5 times the intended dose, according to a press release.
The recall includes Relion 1 cc, 31-gauge, 100 units for use with U-100 insulin from Lot Number 813900.
During packaging, syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin. The syringes were packaged individually and boxed as 100 units for use with U-100 insulin. Use of the product could lead to hypoglycemia, serious health consequences and even death, according to the FDA.
The product is distributed by Can-Am Care and is only sold at Wal-Mart and Sam’s Club stores. Any customers who have purchased the recalled product are asked to return it to the Wal-Mart or Sam’s Club pharmacy for a replacement product.
Health care professionals and patients are urged to check syringe packaging for those labeled as 100 units for use with U-100 insulin from Lot Number 813900.
Covidien voluntarily recalled the lot on Oct. 9, 2008 and required that all units of the affected product be removed from inventory and quarantined. The company has received one report of a related adverse event.
Health care professionals and consumers are urged to report adverse events to the FDA’s MedWatch Adverse Events Reporting program.
For more information or to report an event, go to www.fda.gov/MedWatch/report.htm.