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
Reported: October 11, 2023 Initiated: September 21, 2023 #D-0038-2024
Product Description
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
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 7,248 bottles
- Distribution
- Nationwide in the USA.
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 7,248 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 11, 2023. Severity: Moderate. Recall number: D-0038-2024.
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