Reported Mar 22, 2023 · Terminated
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC…
Zydus Pharmaceuticals (USA) Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
Colchicine TabletsUSP 0.6 mgRx Onlya) 30 tablets per bottleNDC 16714-0039-01b) 100 tablets per bottleNDC 16714-0039-02
- Manufactured forNorthStar Rx LLC., Memphis, TN 38141
- Manufactured byZydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01
- Manufactured byCadila Healthcare Ltd., Ahmedabad, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
- Lot codes and dates
Lot #s: a) E203821Exp. 05/2024b) E203822Exp. 05/2024E206186Exp. 10/2024c) E203820Exp. 05/2024
- Amount recalled
- 21,936/30 count bottles and 33,096/100 count bottles
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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