Reported Nov 23, 2016 · Terminated
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel…
GSK Consumer Healthcare
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GSK Consumer Healthcare · 184 Liberty Corner Rd Ste 200 · Warren, NJ · 07059-6868
Is this the product you have?
- Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g)
- Manufactured forSteifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
- Lot codes and dates
- 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.
- Amount recalled
- 462,732 bottles
Where it was sold
- Nationwide
Why it was recalled
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".
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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