Ciclopirox Olamine Cream
FDA Recall NDC 0713-0638
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ciclopirox Olamine (NDC 0713-0638). A significant event, classified as Class III, was initiated on Jan 19, 2018 by Cosette Pharmaceuticals, Inc.. The reported reason for this action was: "Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration."
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
Class III Terminated
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Jan 19, 2018
Feb 14, 2018
142,236 tubes
Recall Profile & Regulatory Data
Event ID
78974
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
G & W Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Feb 03, 2020
Product Description
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Batch or Lot Expiration Information
Lot# : a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19
Affected Packages Involved in this Recall
0713-0638-15Product
0713-0638-31Product
0713-0638-18Product
Class III Terminated
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Mar 20, 2017
Apr 12, 2017
230,700 tubes
Recall Profile & Regulatory Data
Event ID
76767
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
G & W Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Feb 14, 2018
Product Description
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
Batch or Lot Expiration Information
Lot# : a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18.
Affected Packages Involved in this Recall
0713-0638-15Product
0713-0638-31Product
0713-0638-18Product
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.
