Drug recall D-0467-2023
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 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.
Lots and codes
Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 21,936/30 count bottles and 33,096/100 count bottles
- Distribution
- AZ, OH, MS.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 24, 2023
- Terminated
- July 1, 2025
Related products
- NDC 70710-1351 Colchicine · Colchiceine .6 mg/1 · Zydus Pharmaceuticals USA Inc.