American Regent has issued a nationwide voluntary recall of three lots of Cyanocobalamin Injection 1,000mcg/mL (1mL vial), because cracks can form in the heel (bottom) and sides of some vials of these lots. These cracks may lead to a lack of assurance of sterility and the potential for development of glass particulates, which can damage the muscle and adipose tissue upon injection.

The recalled lots include Lot# 1662, 1679, and 1683 with an expiration date of November 2013. Although cracks were only observed in lot 1683, American Regent is also recalling lots 1662 and 1679 because these lots were manufactured with the same lot of glass vials as lot 1683. All healthcare facilities and providers should immediately quarantine any product for return.

Cyanocobalamin Injection, USP is indicated in pernicious anemia, vitamin B12 absorption test (Schilling test), and vitamin B12 deficiencies due to malabsorption.

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