FDA recall D-0766-2022

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

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-04-05

Report date

2022-04-20

Termination date

2024-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0766-2022