drugs Class II Updated 2014-01-29

KVK-Tech, Inc. recalls HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: NDC: 10702-011-01: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp.May-14; lot #10790, exp. Jun-14; lot # 10791, exp. Jun-14: lot # 10792, exp. Aug-14; lot #10983, exp. Sep-14; lot #10984, exp.Sep-14; lot #10986, exp. Oct-14; lot # 11034, exp. Nov-14; lot #11035, exp. Dec-14; lot # 11036, exp. Dec-14; lot #11435, exp. Nov-15. NDC: 10702-011-10: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot #10789, exp. May-14; lot #10790, exp. Jun-14; lot #10791, exp. Jun-14; lot #10792, exp. Aug-14; lot # 10983, exp. Sep-14; lot #10985, exp. Oct-14; lot #11034, exp. Nov-14; lot #11038, exp. Dec-14; lot #11435, exp. Nov-15. NDC: 10702-011-50: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp. May-14; lot #10791, exp. Jun-14; lot# 10792, exp. Aug-14; lot # 10983, exp. Sep-14; lot # 10985, exp. Oct-14; lot # 10986, exp. Oct-14; lot # 11037, exp. Dec-14; lot #11435, exp. Nov-15.
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