Zydus Pharmaceuticals (USA) Inc 2023-03-22 Health moderate FDA
Health · FDA · Recall #FDA-D-0467-2023
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b)… Recall
Issued March 22, 2023 · Zydus Pharmaceuticals (USA) Inc
In March 2023, Zydus Pharmaceuticals (USA) Inc recalled the Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b)…, a moderate health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b)… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zydus Pharmaceuticals (USA) Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zydus Pharmaceuticals (USA) Inc
- Category
- Health
- Recall date
- March 22, 2023
- Units affected
- Not reported
- Sold at
- AZ, OH, MS.
- Recall number
- FDA-D-0467-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Zydus Pharmaceuticals (USA) Inc has 31 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.