Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare L
Recalled November 15, 2023 · FDA recall D-0097-2024 · Zydus Pharmaceuticals (USA)
Hazard
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. · FDA Class II
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Nationwide.
Description
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Product
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →