FDA Drug recall D-1031-2014
HydrOXYzine HCI Tablets USP 25 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 25 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-1031-2014 |
| 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 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.
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: 10702-011-01: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp.May-14; lot #10790, exp. Jun-14;…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. |
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-1031-2014%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.