FDA Drug recall D-0467-2023
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufac…
- FDA Drug
- Class III
- terminated
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class III recall of Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufac… by Zydus Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0467-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-02-24 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | AZ, MS, OH |
Product
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
Reason
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Identifiers
| code_info | Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024. |
|---|
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-0467-2023%22
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