Zydus Pharmaceuticals (USA) Inc: Drug Recall
Recall #D-0467-2023 · 02/24/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-0467-2023
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Status
- Terminated
- Date Initiated
- 02/24/2023
- Location
- Pennington, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,936/30 count bottles and 33,096/100 count bottles
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.
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.
Distribution Pattern
AZ, OH, MS.
Other Recalls by Zydus Pharmaceuticals (USA) Inc
- Class II: Risk 12/30/2025
- Class III: Low Risk 12/19/2025
- Class II: Risk 10/23/2025
- Class II: Risk 10/22/2025
- Class II: Risk 10/22/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.