Kristian Rasmussen November 12th, 2008
Company Recalls 471,000 ReliOn Insulin Syringes Because of Possible Mislabeling and Overdose Risk
Tyco Healthcare Group LP (Covidien), has recalled one lot of ReliOn sterile, single-use hypodermic syringes sold at Wal-Mart and Sam’s Clubs stores The FDA recalled the syringes because they contained more than twice the intended dose reflected on the package and therefore were mislabeled. Patients are advised of the serious health risks associated with receiving the high dose including, hypoglycemia and death. One incident has been reported, according to the Food and Drug Administration.
“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,” according to an FDA news release.
The recall only applies to the following products:
- Product name: ReliOn Insulin Syringes – 31 gauge 1 cc (100 syringes per box)
- Lot number: 813900 (on the back panel of the carton, or on the white paper backing of each syringe’s “peel pack”)
- Product identification number: 38396-0403-02 (on the top panel upper right-hand corner of the syringe box)
The FDA says some syringes labeled for use with U-40 insulin got packaged with syringes for U-100 insulin. For additional information please contact Cory Watson attorneys Kristian Rasmussen, krasmussen@cwcd.com or Jerome Tapley, jtapley@cwcd.com or phone (800) 852-6299.