FDA recall D-0038-2024

Product

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

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-09-21

Report date

2023-10-11

Termination date

2025-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0038-2024