HydrOXYzine HCI Tablets USP 10 mg — Class II drug recall D-1030-2014
Terminated recall by KVK-Tech, Inc., reported 2014-01-29, distributed nationwide. Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapprove
| Recall number | D-1030-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KVK-Tech, Inc., Newtown, PA, United States |
| Recall initiated | 2013-12-11 |
| Classified | 2014-01-22 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2015-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 14,664 bottles |
| Reason classes | cgmp, unapproved product |
| NDC | 10702-0010, 10702-0010-01, 10702-0010-10, 10702-0010-50, 10702-0011, 10702-0011-01, 10702-0011-10, 10702-0011-50, 10702-0012, 10702-0012-01, 10702-0012-10, 10702-0012-50 |
| Lot numbers | 11434, NOV-14 |
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 for recall
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1030-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.