FDA recall D-0235-2022

Teva Pharmaceuticals USA · Class III · drug

Product

Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2021-10-28
Report date
2021-11-24
Termination date
2023-02-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0235-2022