Reported Nov 15, 2023 · Completed
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only
- Manufactured byCadila Healthcare Ltd, Baddi, India
- Distributed byZydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01
- Lot codes and dates
M211541exp. date 10/2024 M211542exp. date 10/2024 M212746exp. date 10/2024 M300660exp. date 12/2024
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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