New York-based distributor American Regent Inc., a part of Luitpold Pharmaceuticals Inc., has announced a nationwide recall of three lots of Cyanocobalamin Injection as cracks can form in the bottom and sides of some vials of these lots.
The cracks may lead to a lack of assurance of sterility and the potential for development of glass particulates.
The product bears the name Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 mL Vial NDC # 0517-0031-25, and the lots being recalled are:
Lot # 1662, Lot # 1679, and Lot # 1683, and all having their expiry date as November 2013.
American Regent noted that although cracks were only observed in lot 1683, as a precautionary measure it is also recalling the other two lots as they were manufactured with the same lot of glass vials as lot 1683.
The product was distributed to wholesalers and distributors nationwide. The company is advising Hospitals, Retail Pharmacies, Clinics and Physician Offices, and other facilities not to use the aforesaid product lots.
American Regent said it has not received any reports of adverse events related to these lots.
According to the company, the subcutaneous injection of a solution whose sterility may have been compromised may result in a systemic infection, abscess formation, or infection at the injection site.
Further, muscle and adipose tissue damage may occur by the intramuscular or subcutaneous injection of solutions containing particulates.
Cyanocobalamin Injection is indicated for vitamin B12 deficiencies due to malabsorption. The product is manufactured by Luitpold Pharmaceuticals Inc., which is a part of Daiichi Sankyo Group.
by RTT Staff Writer
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