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American Regent recalls Vitamin B-12 injections due to cracked vials

Filed April 5th, 2012 Joshua Sophy

American Regent has issued a recall on three Lots of its Cyanocobalamin Injection because the vials may be cracked.

A cracked vial on an injection drug could compromise the safety and sterility of the injection. This could lead to severe internal injuries if cracked vials have splintered any glass fragments into the drug and the drug is then injected into a patient. Foreign materials could also contaminate a drug in a vial, putting a patient at serious risk of infection or other injuries.

According to a recall statement from America Regent, the recall on Cyanocobalamin Injection (1000 mcg/ML) includes the following four Lot numbers, each with an expiration date of November 2013: 1662, 1679, and 1683. The recall was announced on April 2, specifically to the attention of retail and hospital pharmacists.

Cracks in the vials of Lot 1683 prompted American Regent to include three other Lots out of precaution. The company warns in its recall statement that “systemic infection, abscess formation, or infection at the injection site” could result from being injected with a vial containing small glass particulates.

The injection drug included in this recall is used to overcome Vitamin B-12 shortfalls in patients. No adverse reaction reports were filed to spur this recall from American Regent.

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