FDA recall D-0990-2019

AVKARE Inc. · Class III · drug

Product

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2019-03-01
Report date: 2019-03-20
Termination date: 2020-01-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0990-2019