D-0766-2022 Class III Terminated
FDA drug recall D-0766-2022 was initiated by Aurobindo Pharma USA Inc. on April 5, 2022 and is designated Class III. Reason for recall: Subpotent Drug: Out of Specification results for Assay The recall status is terminated (terminated June 27, 2024). Affected quantity: 433,809 vials.
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.