Novartis Recalls Lamisil AT Antifungal Cream Due to Illegible Labeling
Novartis Consumer Health is recalling 3,828 tubes of Lamisil AT antifungal 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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is limited to packaging/labeling legibility.
Plain-English summary
Novartis Consumer Health is voluntarily recalling 3,828 tubes of Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, NDC 0067-6171-85. The recall is limited to Lot #10118124 with an expiration date of September 2013.
The recall was initiated because the lot and/or expiration date on the tube may not be legible. This labeling issue prevents consumers from verifying the product's identity and expiration status. The affected product was distributed nationwide.
Consumers who have this specific lot of Lamisil AT should stop using it and contact Novartis Consumer Health for a refund or replacement. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 3,828
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)
- Lot #: 10118124
- Exp: Sept 2013
Distribution
Distributed nationwide across the United States.
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