Recall D-0467-2023
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.
Recall D-0467-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0467-2023 |
Event ID | 91770 |
Distribution | AZ, OH, MS. |
Quantity | 21,936/30 count bottles and 33,096/100 count bottles |
Recall 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. |
Drug Classification | Class III |
Drug Code Info | 20230322 |
Recall Initiation Date | 20230224 |
Report Date | 20230322 |
Classification Date | 20230314 |
Address | 73 Route 31 N Pennington, NJ 08534-3601 United States |
Recalling Firm | Zydus Pharmaceuticals (USA) Inc |
Initial Notification | Letter |
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