D-0766-2022 Class III Terminated

Recalled by Aurobindo Pharma USA Inc. — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
April 20, 2022
Initiation Date
April 5, 2022
Termination Date
June 27, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
433,809 vials

Product Description

Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.

Reason for Recall

Subpotent Drug: Out of Specification results for Assay

Distribution Pattern

Nationwide in the USA.

Code Information

Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.