Cyanocobalamin injection is being recalled by American Regent for cracked vials, the U.S. Food & Drug Administration (FDA) just announced. Cyanocobalamin Injection, USP, is manufactured by Luitpold Pharmaceuticals, Inc. and distributed by American Regent, Inc. of Shirley, New York.
American Regent is conducting this nationwide recall at the retail and hospital level for Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 mL Vial NDC # 0517-0031-25. The recall involves Lot Number 1662 and Expiration Date: November 2013; Lot Number 1679 and Expiration Date: November 2013; and Lot Number 1683 and Expiration Date: November 2013. The recall was initiated on April 2, 2012 and involves no other lots or sizes of Cyanocobalamin Injection, USP.
American Regent learned that cracks can form in the heel (bottom) and sides of some vials of the recalled lots. This may lead to contamination and the potential for glass particulates. Cracks were observed in lot 1683; however, lots 1662 and 1679 are also being recalled because they were manufactured with the same lot of glass vials as lot 1683. To date, American Regent has not received any reports of adverse events related to these defective lots.
The intramuscular or 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, said the FDA. Muscle and adipose tissue damage may occur when solutions containing particulates are injected intramuscularly or subcutaneously.
Cyanocobalamin Injection, USP is indicated for vitamin B12 deficiencies due to malabsorption, which may be associated with Addisonian (pernicious) anemia; gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, or total or partial gastrectomy; fish tapeworm infestation; malignancy of the pancreas or bowel; or folic acid deficiency.
The recalled Cyanocobalamin Injection, USP was distributed to wholesalers and distributors nationwide. Hospitals, retail pharmacies, clinics and physician offices, and other healthcare facilities and providers are advised to not use the recalled American Regent Cyanocobalamin Injection, USP. These products should be immediately quarantined for return.
American Regent is advising its distributors and consumers by email, fax, and/or overnight courier of the recall and is arranging for return of all the recalled Cyanocobalamin Injection, USP. Consumers, distributors, and retailers in possession of the recalled Cyanocobalamin Injection, USP are advised to stop its use.
American Regent said it will credit accounts for all returned recalled Cyanocobalamin Injection. American Regent Customer Service can be reached, toll-free, at 1.800.645.1706, Monday through Friday, from 8:30 a.m. to 7:00 p.m., Eastern Time (ET). Hospitals, emergency rooms, clinics, and other healthcare facilities and providers, or patients with product quality complaints, medical, or other questions can reach Professional Services, toll-free, at 1.877.788.3232, Monday through Friday, from 9:00 a.m. to 5:00 p.m., ET. Adverse reactions should be reported to American Regent via email at firstname.lastname@example.org; by fax to 1.610.650.0180, or by telephone, toll-free, at 1.800.734.9236, Monday through Friday, 9:00 am. to 5:00 p.m., ET.
Adverse reactions or quality problems should also be reported to FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax: Online: www.fda.gov/medwatch/report.htm; Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form; or Fax: 1-800-FDA-0178.