Recall archive / FDA drug enforcement
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC ... — FDA record D-0467-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Quantity
- 21,936/30 count bottles and 33,096/100 count bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0467-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AZ, OH, MS.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 22, 2023
- Recall initiation date
- Feb 24, 2023
- Center classification date
- Mar 14, 2023
- Termination date
- Jul 1, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.