American Regent has pulled lots of its cyanocobalamin injection due to cracked vials, which may compromise product sterility and possibly lead to the development of glass particles.

The three affected lots of Cyanocobalamin Injection USP, 1000 mcg/mL, 1 mL may form cracks at the bottom and sides of their vials. Glass particles in the vials may cause muscle and adipose tissue damage, while compromised sterility may result in systemic infection, abscess formation, and injection-site infection.

Although cracks were only observed in one of the three lots, the additional two lots contain vials manufactured from the same lot of glass vials as the cracked samples, according to a statement from the drugs and devices distributor.

The recall includes lot numbers 1662, 1679, and 1683.

Since December 2010, the company has recalled 12 products for potency issues and debris in intravenous solutions. Devices from other companies have also faced recalls because they were packaged with affected American Regent products. The company’s previous recall was because a single lot of phenylephrine injection - a blood pressure drug - contained visible particles.

Cyanocobalamin is indicated for treatment of vitamin B12 deficiencies due to malabsorption associated with pernicious anemia, gastrointestinal pathology, dysfunction, or surgery; fish tapeworm infestation; malignancy of the pancreas or bowel; and folic acid deficiency.

Vials from the recalled lot were distributed to wholesalers and distributors in the U.S. The company is contacting customers to arrange for a return of affected products.

No adverse events related to the recall have been reported.

The drug is manufactured by Luitpold Pharmaceuticals.

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By Cole Petrochko, Associate Staff Writer, MedPage Today