D-0467-2023 Class III Terminated
FDA drug recall D-0467-2023 was initiated by Zydus Pharmaceuticals (USA) Inc on February 24, 2023 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated July 1, 2025). Affected quantity: 21,936/30 count bottles and 33,096/100 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 22, 2023
- Initiation Date
- February 24, 2023
- Termination Date
- July 1, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,936/30 count bottles and 33,096/100 count bottles
Product Description
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 for Recall
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.
Distribution Pattern
AZ, OH, MS.
Code Information
Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.