Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0467-2023
Event ID91770
DistributionAZ, OH, MS.
Quantity21,936/30 count bottles and 33,096/100 count bottles
Recall ReasonFailed 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 ClassificationClass III
Drug Code Info20230322
Recall Initiation Date20230224
Report Date20230322
Classification Date20230314
Address73 Route 31 N
Pennington, NJ 08534-3601
United States
Recalling FirmZydus Pharmaceuticals (USA) Inc
Initial Notification Letter
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