FDA Recall Lamisil AT

The last Recall Enforcement Report for Lamisil AT with NDC 0067-3998 was initiated on 02-19-2013 as a Class III recall due to 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. The latest recall number for this product is D-573-2013 and the recall is currently terminated as of 11-26-2014 .

Recall Number D-573-2013

Field Name	Field Value
Event ID	64372 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-573-2013 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide and Puerto Rico, and Panama. Military distribution made. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.
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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	818,064 (12-gm) tubes and 836,376 (30-gm) tubes Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-12-2013
Recall Initiation Date	02-19-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	11-26-2014 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Novartis Consumer Health
Code Info	(12 gm) Lot numbers and Exp dates: 10109586 30-Apr-2013, 10116816 31 May 2013, 10117695 31-Jul-2013, 10120283 31-Aug-2013, 10104980 28-Feb-2013, 10108711 31-Mar-2013, 10111313 30-Apr-2013, 10111509 30-Apr-2013, 10115506 30-Jun-2013, 10117696 30-Jun-2013, 10120763 31-Aug-2013, 10122695 30-Sep-2013, 10104983 28-Feb-2013, 10108714 31-Mar-2013, 10119643 31-Jul-2013 (30 gm) Lot numbers and Exp dates: 10104979 28-Feb-2013 10108712 31-Mar-2013 10109588 30-Apr-2013 10111507 30-Apr-2013 10115133 31-May-2013 10115619 30-Jun-2013 10117694 31-Aug-2013 10120762 30-Sep-2013 10109981 31-Mar-2013 10111316 31-Mar-2013 10114223 31-May-2013 10117697 30-Jun-2013 10104982 28-Feb-2013 10108355 31-Mar-2013, 10112072 30-Apr-2013, 10112073 30-Apr-2013 10113501 31-May-2013, 10122772 31-Aug-2013 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0067-3998-42; 0067-3998-30; 3006739984; 3006739981; 0067-3998-12; 3006739983; 0067-3998-33
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
	View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.