April 2013 FDA Recall Drug by Novartis Consumer Health
D-420-2013 - Labeling

This Class III drug recall was voluntarily initiated by Novartis Consumer Health on April 19, 2013 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-420-2013

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Initiated
04-19-2013
Reported
05-29-2013
Quantity
3,828 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65021
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.
Novartis Consumer Health
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2014
Product Description About Product Description
Full technical description of the product.
Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85

Batch or Lot Expiration Information

Lot# : 10118124, Exp: Sept 2013