February 2019 FDA Recall Ciclopirox by Perrigo New York, Inc.
D-0512-2019 - Failed Degradation/Impurities Specifications

This Class III drug recall was voluntarily initiated by Perrigo New York, Inc. on February 13, 2019 for the product Ciclopirox. The FDA reported the reason for recall as failed degradation/impurities specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0512-2019

Reason for Recall
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Initiated
02-13-2019
Reported
02-27-2019
Quantity
12252 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo New York, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-08-2021
Product Description About Product Description
Full technical description of the product.
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

45802-401-09 Ciclopirox