The Recall Desk
LowFDA (Drugs)·D-576-2013·Announced 2013-06-12

Novartis Recalls Lamisil AT Cream Due to Illegible Labeling

Novartis Consumer Health is recalling specific lots of Lamisil AT Cream because the lot and expiration dates on the tubes may be illegible.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is limited to packaging/labeling legibility issues.

Plain-English summary

Novartis Consumer Health is voluntarily recalling 41,400 boxes of Lamisil AT Cream (terbinafine hydrochloride 1% antifungal). The recall involves 12 gm and 30 gm tubes packaged in one box (Club Pack) with NDC 0067-6295-43. The affected products are identified by Lot numbers 10109590 and 10111050, with an expiration date of 2/28/13.

The recall was initiated because the lot and/or expiration date on the tube may not be legible for these specific lots. This labeling issue could prevent consumers from verifying the product's identity and expiration status.

The affected products were distributed nationwide, in Puerto Rico, and in Panama, including military distribution. Consumers who have these specific lots should stop using the product and contact Novartis Consumer Health for a refund or replacement.

The recalled product

Product
Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
Affected units
41,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #: 10109590
  • 10111050
  • Exp 2/28/13.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →