Class III
Terminated
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.
This recall has been terminated (originally issued March 22, 2023).
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- February 24, 2023
- Posted
- March 22, 2023
- Recall Number
- D-0467-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 21,936/30 count bottles and 33,096/100 count bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
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
AZ, OH, MS.
Lot / Code Info
Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.
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