PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 27, 2019 Initiated: February 13, 2019 #D-0512-2019

Product Description

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.

Details

Recalling Firm
Perrigo New York, Inc.
Units Affected
12252 bottles
Distribution
Nationwide within the United States
Location
Bronx, NY

Frequently Asked Questions

What product was recalled?
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09. Recalled by Perrigo New York, Inc.. Units affected: 12252 bottles.
Why was this product recalled?
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 27, 2019. Severity: Low. Recall number: D-0512-2019.