KVK-Tech, Inc. recalls HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940.
Recalled January 29, 2014 · FDA recall D-1031-2014 · KVK-Tech
Hazard
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. · FDA Class II
Units
249,096 bottles
Sold at
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Description
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Product
HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.
Manufacturer(s)
KVK-Tech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →