Ciclopirox Shampoo
FDA Recall NDC 45802-401
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ciclopirox (NDC 45802-401). A significant event, classified as Class III, was initiated on Feb 13, 2019 by Padagis Israel Pharmaceuticals Ltd. The reported reason for this action was: "Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
February 2019 Class III Recall: Failed Degradation/Impurities Specifications
Recall Number
Class III Terminated
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Feb 13, 2019
Feb 27, 2019
12252 bottles
Recall Profile & Regulatory Data
Event ID
82127
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Perrigo New York, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 08, 2021
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
Batch or Lot Expiration Information
Lot# : 7DT0280, 7ET0565, Exp. 02/19
Affected Packages Involved in this Recall
45802-401-09Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
