FDAClass IIIFebruary 27, 2019

Ciclopirox shampoo 1% recall: Impurity Out of Spec

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

Why was Ciclopirox shampoo 1% recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 7DT0280, 7ET0565, Exp. 02/19

Product
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Recalling firm
Perrigo New York, Inc.
Quantity
12252 bottles
Distribution
Nationwide within the United States
Recall date
February 27, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls