Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67103

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 11, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
KVK-Tech, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.

D-1030-2014
Recall number
D-1030-2014
Initiated
December 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
KVK-Tech, Inc.
Quantity
14664 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Good Manufacturing Practices Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

lot #11434, exp. Nov-14

Distribution pattern

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

drug · product 2 of 3

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.

D-1031-2014
Recall number
D-1031-2014
Initiated
December 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
KVK-Tech, Inc.
Quantity
249,096 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Good Manufacturing Practices Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

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

drug · product 3 of 3

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.

D-1032-2014
Recall number
D-1032-2014
Initiated
December 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
KVK-Tech, Inc.
Quantity
104551 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Good Manufacturing Practices Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.