October 2016 FDA Recall Drug by Gsk Consumer Healthcare
D-0142-2017 - Labeling Not Elsewhere Classified

This Class III drug recall was voluntarily initiated by Gsk Consumer Healthcare on October 18, 2016 for the product Drug. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0142-2017

Reason for Recall
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Initiated
10-18-2016
Reported
11-23-2016
Quantity
462,732 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75482
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.
GSK Consumer Healthcare
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2018
Product Description About Product Description
Full technical description of the product.
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01

Batch or Lot Expiration Information

Lot# : 5M02ST*, 5M03ST*, 5M04ST*, Exp 10/17; 5P01ST, 5P01STA, 5P02ST, 5P03ST, 5P04ST, 5P05ST, Exp 11/17; 6C03ST, 6C04ST, 6C05ST, 6C06ST, 6C07ST, Exp 02/18 *Lots 5M02ST, 5M03ST, and 5M04ST contain the NDC code error only on front label, back label is correct.