American Health Packaging recalls HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255
Recalled April 9, 2014 · FDA recall D-1189-2014 · American Health Packaging
Hazard
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. · FDA Class II
Units
8,570 blister packs
Sold at
Nationwide
Description
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Product
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Manufacturer(s)
American Health Packaging
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →