FDA Drug recall D-1032-2014
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only by Kvk Tech, citing good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1032-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-11 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Kvk Tech |
| Distribution | US |
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.
Reason
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Identifiers
| ndc | 10702-010-01 |
|---|---|
| ndc | 10702-010-50 |
| ndc | 10702-010-10 |
| ndc | 10702-011-01 |
| ndc | 10702-011-50 |
| ndc | 10702-011-10 |
| ndc | 10702-012-01 |
| ndc | 10702-012-50 |
| ndc | 10702-012-10 |
| code_info | NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; 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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1032-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.