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D-0142-2017 Class III Terminated

Recalled by GSK Consumer Healthcare — Warren, NJ

Recall Details

Product Type: Drugs
Report Date: November 23, 2016
Initiation Date: October 18, 2016
Termination Date: November 8, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 462,732 bottles

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".

Distribution Pattern

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.