Consumers, who use Ultilet Syringe Insulin product lot 5GEXI, have been requested to stop usage and return the specific product. Even the wholesalers were advised to stop retail and return the product lot to Boca Medical Products Inc, 3550 NW 126th Ave, Corals Springs, FL 33065. Attention: Recall Contact. For any question related to the case consumers should call 1-800-354-8460.
The recall include the following product:
Product Description - Ultilet Insulin Syringe 30g ― cc
Lot - 5GEXI
NDC # - 08326-3002-50
A single complaint and a reported event prompted a Company investigation, which is on going. The compliant stated that when the syringe was used, the color of the insulin solution entering the syringe chamber changed. The firm decision to recall the product lot is voluntary. The firm has placed all inventory of the product on hold. FDA has been apprised of this action.
No serious injury has been reported. No other lot is included on this Recall.