American Regent Cyanocobalamin Recall: Cracked Vials

Three lots of Cyanocobalamin, a drug used to treat vitamin B12 deficiencies, have been recalled after some vials of the drug were found to be cracked. 

The Cyanocobalamin recall was announced by the FDA on April 2, after the cracks were discovered by the manufacturer, American Regent.

While the cracks were only found in one lot, American Regent indicates that it is including two other lots in the recall because they were made with the same lot of glass vials.

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The cracks could result in a loss of sterility of the drug. They could also cause glass particles to infiltrate the drug, which can cause damage to veins and result in embolism if injected into a patient. American Regent says it has received no reports of injury, illness or cracks from customers.

The recall affects three lots of Cyanocobalamin injection, USP, 100 mcg/mL in 1 mL vials. The lot numbers are 1662, 1679 and 1683. The drugs have an NDC number of 0517-0031-25 and an expiration date of November, 2013.

Cyanocobalamin is used to treat patients who are vitamin B12 deficient due to malabsorbtion. This problem can be caused by Addisonian anemia, gastrointestinal problems, a fish tapeworm infestation, malignancy of the pancreas or bowel or a folic acid deficiency.

The recall is occurring on the retail and hospital level. American Regent and the FDA are warning hospitals, pharmacies, clinics and other health care venues that may have received the drug not to use it if it comes from one of the affected lots. They should immediately quarantine those lots and return them to American Regent.

The company is in the process of notifying customers and distributors about the recall and arranging for the return of affected vials. The accounts of all customers who have to return recalled vials will be credited. Customers with questions can call American Regent’s customer service at (800) 645-1706.


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