The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-575-2013·Announced 2013-06-12

Novartis Lamisil AT Cream Recalled for Illegible Lot and Expiration Dates

Novartis is recalling 219,600 tubes of Lamisil AT Cream because the lot and expiration dates may be illegible.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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 is defined as unlikely to cause adverse health consequences. The hazard is a documentation/labeling issue (illegible dates) rather than a direct safety defect.

Plain-English summary

Novartis Consumer Health is recalling 219,600 tubes of Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal). The recall involves 12 g (.42 oz) tubes in both vertical and horizontal packaging configurations.

The recall was initiated because the lot and expiration dates on the tubes may not be legible. This labeling issue prevents consumers from verifying the specific lot number and expiration date of the product.

The affected products were distributed nationwide, in Puerto Rico, and in Panama, with military distribution also made. Consumers should check their tubes for the specific lot numbers and expiration dates listed in the recall notice and stop using the product if it matches the recalled items.

The recalled product

Product
Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC…
Manufacturer
Novartis Consumer Health
Category
Drug — Topical Antifungal
Hazard
Affected units
219,600

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 (2)

  • 10111508 31-May-2013
  • 10119095 31-Jul-2013 and 10119096 30-Sep-2013 (Horizontal package).

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 →

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