Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.
Why it was recalled
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.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 21,936/30 count bottles and 33,096/100 count bottles
- Distribution pattern
- AZ, OH, MS.
Timeline
- Recall initiated
- 2023-02-24
- FDA classified
- 2023-03-14
- Posted by FDA
- 2023-03-22
- Terminated
- 2025-07-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0467-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.