In October/November 2008, 471,000 ReliOn insulin syringes were recalled because of possible overdose risk caused by mislabeling.
If you buy your insulin syringes at Wal-Mart or Samís Clubs stores, you could be at risk. The mislabeling caused the ReliOn insulin syringes to have 2.5 times the intended dose. Diabetics receiving more insulin than required can lead to hypoglycemia, serious health issues, and death.
The ReliOn insulin syringes are single use 31 gauge 1 cc (100 syringes per box) with a lot number of 813900 on the back panel of the carton, or on the white of backing of each syringeís peel pack. The product identification number is 38396-0403-02, which is on the top panel, upper right hand corner of the syringe box.
According to the FDA, some syringes labeled for use with U-40 insulin got packaged with syringes for U-100 insulin.
On October 9, 2008, Tyco recalled the lot voluntarily asking that any units of the affected product be removed from inventory and placed in quarantine. The recall was posted in stores and posted on the website. Wal-Mart sent letters to more than 16,500 customers notifying them of the recall. On October 16, Covidien notified the FDA of the recall. On November 5, the FDA notified healthcare professionals of the recall.
Why did 7 days pass before the maker of insulin syringes notified the FDA?
Why was there almost a month long gap before healthcare professionals were notified of the recall?
If you or a family member has experienced serious side effects or even death from the mislabeled ReliOn insulin syringes, please contact the law firm of Anapol Schwartz. You may be eligible for a ReliOn class action suit. Please contact us for your no-cost, no-obligation consultation.