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
Zydus Pharmaceuticals (USA) Inc
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-0038-2024Don't want to check this manually?
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