Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Completed
Report date
2023-11-15
Distribution
Nationwide.
Firm state
NJ
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Product description
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
Code / lot info
M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.