Drug Enforcement D-0038-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class II

Report Date

October 11, 2023

Termination Date

August 6, 2025

Product Information

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
Product quantity
7,248 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0038-2024
Event ID
93100
Recall initiation date
September 21, 2023
Center classification date
October 4, 2023
Code info
Lot#: M300652 and M300651, exp. Dec 2024
More code info
—