American Regent is conducting a nationwide recall to the Retail/Hospital level of the following product:
Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 mL Vial NDC # 0517-0031-25
Lot # 1662, Exp Date: November 2013
Lot # 1679, Exp Date: November 2013
Lot # 1683, Exp Date: November 2013
American Regent is undertaking this recall of Cyanocobalamin Injection, USP, because cracks can form in the heel (bottom) and sides of some vials of these lots. These cracks may lead to a lack of sterility and the potential for development of glass particulates.
Although cracks were only observed in lot 1683, American Regent, as a precautionary measure, is also recalling lots 1662 and 1679 because these lots were manufactured with the same lot of glass vials as lot 1683.
The intramuscular or subcutaneous injection of a solution whose sterility may have been compromised may result in a systemic infection, abscess formation, or infection at the injection site. Muscle and adipose tissue damage may occur by the intramuscular or subcutaneous injection of solutions containing particulates.
Cyanocobalamin Injection, USP, is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia; gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy; fish tapeworm infestation; malignancy of pancreas or bowel; folic acid deficiency.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, Retail Pharmacies, Clinics and Physician Offices, and other healthcare facilities and providers should not use American Regent Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 mL vials, with lot numberss 1662, 1679, or 1683 for patient care and should immediately quarantine any product for return.
See the Product Recall