Drug recall D-0038-2024
Product
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
Reason for recall
Failed Dissolution Specifications
Lots and codes
Lot#: M300652 and M300651, exp. Dec 2024
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 7,248 bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 21, 2023
- Terminated
- August 6, 2025
Related products
- oxybutynin – drug information
- NDC 68382-255 oxybutynin · Oxybutynin Chloride 5 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-257 oxybutynin · Oxybutynin Chloride 15 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-256 oxybutynin · Oxybutynin Chloride 10 mg/1 · Zydus Pharmaceuticals USA Inc.