Zydus Pharmaceuticals (USA) Inc 2023-11-15 Health serious FDA
Health · FDA · Recall #FDA-D-0098-2024
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only,… Recall
Issued November 15, 2023 · Zydus Pharmaceuticals (USA) Inc
In November 2023, Zydus Pharmaceuticals (USA) Inc recalled the Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only,…, a serious 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 Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
What you should do
- 1 Stop using Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only,… 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
- November 15, 2023
- Units affected
- Not reported
- Sold at
- Nationwide.
- Recall number
- FDA-D-0098-2024
- 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.