Cyanocobalamin Injection 1,000 mcg/mL vials recalled

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American Regent has issued a nationwide voluntary recall of three lots of Cyanocobalamin Injection 1,000 mcg/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 manufacturer warned.

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 health-care facilities and providers should immediately quarantine any product for return.

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; and folic acid deficiency.

Clinicians with questions about the return or recall process can call the American Regent Customer Service Department at 1-800-645-1706, Monday through Friday, 8:30 am to 7:00 pm, eastern time (ET).

Hospitals, emergency rooms, clinics and other health-care facilities and providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for the recall should contact the manufacturer's Professional Services Department at 1-877-788-3232, Monday through Friday, 9:00 am to 5:00 pm, ET.

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