Drug recall D-0766-2022

Class III Terminated reported Apr 20, 2022

Product

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

Lots and codes

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

Recall details

Recalling firm
Aurobindo Pharma USA Inc., East Windsor, NJ
Quantity
433,809 vials
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
April 5, 2022
Terminated
June 27, 2024

Related products