GSK Consumer Healthcare recalls Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Labora…

Recall date

October 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0142-2017

FDA classification

Class III

Brand / firm

GSK Consumer Healthcare

Sold / distributed

Nationwide in the USA

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".

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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