FDA Drug recall D-0766-2022
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 LL…
- FDA Drug
- Class III
- terminated
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class III recall of 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 LL… by Aurobindo Pharma Usa, citing subpotent Drug: Out of Specification results for Assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0766-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-04-05 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
Subpotent Drug: Out of Specification results for Assay
Identifiers
| ndc | 55150-364-01 |
|---|---|
| ndc | 55150-364-10 |
| ndc | 55150-364-25 |
| code_info | Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0766-2022%22
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