Recalls / Class III

Class IIID-0142-2017

Product

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

Affected lot / code info

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.

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".

Recalling firm

Firm

GSK Consumer Healthcare

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

184 Liberty Corner Rd Ste 200, N/A, Warren, New Jersey 07059-6868

Distribution

Quantity

462,732 bottles

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2016-10-18

FDA classified

2016-11-17

Posted by FDA

2016-11-23

Terminated

2018-11-08

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0142-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.