The use of these syringes 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. 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.
Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. 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.The manufacturer has received one adverse report related to a syringe from this product lot
.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.
Filed under Diabetes Drug, Insulin | Tags: Can-Am Care Corp, FDA, Hypoglycemia, Lot Number 813900, mislabeling, ReliOn sterile Insulin Syringes, Tyco Healthcare Group LP, U-100 insulin | Comment Below