January 2018 FDA Recall Ciclopirox Olamine by G & W Laboratories, Inc.
D-0250-2018 - Discoloration

This Class III drug recall was voluntarily initiated by G & W Laboratories, Inc. on January 19, 2018 for the product Ciclopirox Olamine. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0250-2018

Reason for Recall
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Initiated
01-19-2018
Reported
02-14-2018
Quantity
142,236 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78974
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.
G & W Laboratories, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2020
Product Description About Product Description
Full technical description of the product.
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

0713-0638-15 Ciclopirox Olamine
0713-0638-31 Ciclopirox Olamine
0713-0638-18 Ciclopirox Olamine