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D-0038-2024Class II

Zydus Pharmaceuticals (USA) Inc

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Terminated
Report date
2023-10-11
Distribution
Nationwide in the USA.
Firm state
NJ
Product quantity
7,248 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications

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

Code / lot info

Lot#: M300652 and M300651, exp. Dec 2024

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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.