Methyl-Cobalamin injectable recalled over sterility concerns

Recall date

August 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Auro Pharmacies, Inc. recalls Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Comp…

Recall number

D-1160-2018

FDA classification

Class II

Brand / firm

Auro Pharmacies, Inc.

Sold / distributed

Nationwide in USA

Why it was recalled

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631