471,000 ReliOn Insulin Syringes Recalled 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 syringes were recalled because of the potential that they are mislabeled and potentially contain more than twice the intended dose.

Patients are advised of the serious health risks associated with receiving the high dose including, hypoglycemia and death. According to the Food & Drug Administration (FDA), one incident has already been reported.

“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. The FDA notes that Tyco Healthcare recalled this lot of syringes in October, and Wal-Mart and Sam’s Club stores have posted information about the recall and notified more than 16,500 customers about the recall.

Insulin is used by diabetics to counter an elevated blood sugar level. In the case of an insulin overdose, the diabetic person’s blood sugar level falls below normal levels, causing the body to go into insulin shock – an extreme form of hypoglycemia. (Hypoglycemia is the medical term for low blood sugar) When a diabetic person is severely hypoglycemic (s)he becomes unconscious, has seizures, or, if the episode lasts too long, can even die.

Click Here for more information from www.fda.gov

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