FDA recall D-0142-2017

GSK Consumer Healthcare · Class III · drug

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

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

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2016-10-18
Report date: 2016-11-23
Termination date: 2018-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0142-2017