FDA-Drug2023-10-11Class II
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
Hazard
Failed Dissolution Specifications
Sold states
Nationwide in the USA.
Affected count
7,248 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0038-2024More Zydus Pharmaceuticals (USA) Inc recalls
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