Key Takeaway
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 0145-150 by GSK Consumer Healthcare was recalled on October 18, 2016. The hazard: Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels...
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 0145-150
Description
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
Hazard / Reason
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Class III: Product that is not likely to cause adverse health consequences.
Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.
Products Affected
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 0145-150
DrugsCompany Information
GSK Consumer Healthcare
Warren, NJ, United States
View all 3 recalls by GSK Consumer Healthcare →Distribution
Nationwide in the USA
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.