FDA recall D-0512-2019

Perrigo New York, Inc. · Class III · drug

Product

Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09

Reason for recall

Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2019-02-13
Report date
2019-02-27
Termination date
2021-09-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bronx, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0512-2019