FDA recall D-0996-2019

Lannett Company Inc. · Class III · drug

Product

Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide, including Puerto Rico.

Key facts

Status
Terminated
Initiation date
2019-02-21
Report date
2019-03-20
Termination date
2020-11-06
Voluntary/Mandated
N/A
Location
Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0996-2019