FDA Drug recall D-1030-2014
HydrOXYzine HCI Tablets USP 10 mg, 100 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 10 mg, 100 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-1030-2014 |
| 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 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
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 | lot #11434, exp. Nov-14 |
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-1030-2014%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.