Class II
Terminated
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
This recall has been terminated (originally issued October 11, 2023).
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- September 21, 2023
- Posted
- October 11, 2023
- Recall Number
- D-0038-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7,248 bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide in the USA.
Lot / Code Info
Lot#: M300652 and M300651, exp. Dec 2024
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