Recall: D-0512-2019

Class III - Minor Violations

Class IIIClassification

2019-02-13Initiated

TerminatedStatus

Perrigo New York, Inc.Firm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.