HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.

Reason: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Code information: NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; lot #10693, exp. Jul-14; lot #10854, Jul-14; lot # 10942, exp. Sep-14; lot #10995, exp.Oct-14; lot # 10996, Nov-14; lot #11138, exp. Feb-15; lot # 11139 Feb-15; lot # 11140, exp. Feb-15; lot # 11445, exp. Nov-15. NDC: 10702-012-10: lot # 10679, exp. Jan-14; lot # 10689, exp. Jun-14; lot # 10941, Sep-14; lot #10997; Nov-14; lot #10998, Nov-14; lot # 10999, Nov-14; lot #11445, exp. Nov-15. NDC: 10702-012-50: lot #10678, exp. Jan-14; lot #10689, exp. Jun-14; lot #10855, exp. Jul-14; lot # 10943, exp. Sep-14; lot # 11136, exp. Feb-15; lot #11137, exp. Feb-15; lot# 11445, exp. Nov-15.

Distribution pattern: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.