Hydroxyzine Hydrochloride Tablet, Film Coated
FDA Recall NDC 10702-010
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Hydroxyzine Hydrochloride (NDC 10702-010). A significant event, classified as Class II, was initiated on Dec 11, 2013 by Kvk-tech, Inc.. The reported reason for this action was: "Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Dec 11, 2013
Jan 29, 2014
104551 bottles
Recall Profile & Regulatory Data
Event ID
67103
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Termination Date
Aug 03, 2015
Product Description
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
10702-010-01Product
10702-010-50Product
10702-010-10Product
10702-011-01Product
10702-011-50Product
10702-011-10Product
10702-012-01Product
10702-012-50Product
10702-012-10Product
Class II Terminated
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Dec 11, 2013
Jan 29, 2014
14664 bottles
Recall Profile & Regulatory Data
Event ID
67103
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Termination Date
Aug 03, 2015
Product Description
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
10702-010-01Product
10702-010-50Product
10702-010-10Product
10702-011-01Product
10702-011-50Product
10702-011-10Product
10702-012-01Product
10702-012-50Product
10702-012-10Product
Class II Terminated
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Dec 11, 2013
Jan 29, 2014
249,096 bottles
Recall Profile & Regulatory Data
Event ID
67103
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Termination Date
Aug 03, 2015
Product Description
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.
Affected Packages Involved in this Recall
10702-010-01Product
10702-010-50Product
10702-010-10Product
10702-011-01Product
10702-011-50Product
10702-011-10Product
10702-012-01Product
10702-012-50Product
10702-012-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
