FDA recall D-1396-2012

Teva Pharmaceuticals USA, Inc. · Class II · drug

Product

Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78

Reason for recall

Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-04-02
Report date: 2012-07-04
Termination date: 2013-03-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1396-2012