KVK-Tech, Inc.: 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 c

Is my product affected?

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.

• Brand HYDROXYZINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

KVK-Tech, Inc. is recalling HydrOXYzine HCI Tablets USP 25 mg in 100, 500, and 1000 count bottles distributed nationwide, including Puerto Rico. The recall affects approximately 249,096 bottles because the active pharmaceutical ingredient came from an unapproved source, which violates Good Manufacturing Practices standards.

The recalled products were distributed to wholesale distributors for sale to retail establishments. Multiple lot numbers are affected across different bottle counts, with expiration dates ranging from February 2014 through November 2015. The record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. Distribution: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments. Quantity: 249,096 bottles 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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