GSK Recalls Zeasorb AF Antifungal Cream Due to Labeling Errors
GSK Consumer Healthcare is recalling Zeasorb AF antifungal cream because some bottles have incorrect NDC codes or indications on the labels.
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 indicates the product is not likely to cause adverse health consequences. The issue is limited to packaging and labeling errors.
Plain-English summary
GSK Consumer Healthcare is voluntarily recalling 462,732 bottles of Zeasorb AF (miconazole nitrate) 2% antifungal cream. The product was distributed nationwide in the United States.
The recall was initiated due to labeling errors. Specifically, some front labels display the incorrect NDC code 0145-1506-01 instead of the correct 0145-1506-05. Additionally, some back labels contain the incorrect indication "use for the cure of most jock itch" rather than the correct "use for the cure of most athlete's foot." The affected lots include 5M02ST, 5M03ST, 5M04ST, 5P01ST, 5P01STA, 5P02ST, 5P03ST, 5P04ST, 5P05ST, 6C03ST, 6C04ST, 6C05ST, 6C06ST, and 6C07ST.
Consumers should check their bottles for these specific lot numbers and expiration dates. If the product matches the recalled description, consumers should stop using it and contact GSK Consumer Healthcare for a refund or replacement.
The recalled product
- Product
- Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
- Manufacturer
- GSK Consumer Healthcare
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 462,732
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 (20)
- Lot #: 5M02ST*
- 5M03ST*
- 5M04ST*
- Exp 10/17
- 5P01ST
- 5P01STA
- 5P02ST
- 5P03ST
- 5P04ST
- 5P05ST
- Exp 11/17
- 6C03ST
- 6C04ST
- 6C05ST
- 6C06ST
- 6C07ST
- Exp 02/18 *Lots 5M02ST
- 5M03ST
- and 5M04ST contain the NDC code error only on front label
- back label is correct.
Distribution
Distributed nationwide across the United States.
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