Multi event Drug Recall Enforcement Report Class II voluntary initiated by KVK-Tech, Inc., originally initiated on 12-11-2013 for the product HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01. The product was recalled due to good manufacturing practices deviations: the product has an active pharmaceutical ingredient from an unapproved source.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1030-2014 | 12-11-2013 | 01-29-2014 | Class II | 14664 bottles | HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01. | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | Terminated |
| D-1032-2014 | 12-11-2013 | 01-29-2014 | Class II | 104551 bottles | 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. | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | Terminated |
| D-1031-2014 | 12-11-2013 | 01-29-2014 | Class II | 249,096 bottles | 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. | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 10702-010 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | Kvk-tech, Inc. | Human Prescription Drug |
| 10702-011 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | Kvk-tech, Inc. | Human Prescription Drug |
| 10702-012 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Tablet, Film Coated | Oral | Kvk-tech, Inc. | Human Prescription Drug |
