Multi-event December 2013 FDA Recall Hydroxyzine Hydrochloride by Kvk-tech, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Kvk-tech, Inc. on December 11, 2013 for the product Hydroxyzine Hydrochloride. The FDA reported the reason for recall as good manufacturing practices deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1032-2014
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
12-11-2013
01-29-2014
104551 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
KVK-Tech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
08-03-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
Recall Number: D-1030-2014
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
12-11-2013
01-29-2014
14664 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
KVK-Tech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
08-03-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
Batch or Lot Expiration Information
Lot# 11434, exp. Nov-14
Affected Packages Involved in this Recall
Recall Number: D-1031-2014
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
12-11-2013
01-29-2014
249,096 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
KVK-Tech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
08-03-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# 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.
