The recall was issued because cracks can form in the heel (bottom) and sides of some vials of 1662, 1679, and 1683 lots.
The cracks may lead to a lack of guarantee of sterility and the possibility for development of glass particulates.
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, the American Regent said.
Cyanocobalamin Injection, USP, indicated for vitamin B12 deficiencies due to malabsorption, is manufactured by Luitpold Pharmaceuticals and is distributed by American Regent.