Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactur...
FDA Recall #D-0142-2017 — Class III — October 18, 2016
Product 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
Reason for Recall
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".
Recalling Firm
GSK Consumer Healthcare — Warren, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
462,732 bottles
Distribution
Nationwide in the USA
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated