FDA Recall Hydroxyzine Hydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Hydroxyzine Hydrochloride with NDC 10702-010 was initiated on 12-11-2013 as a Class II recall due to good manufacturing practices deviations: the product has an active pharmaceutical ingredient from an unapproved source. The latest recall number for this product is D-1031-2014 and the recall is currently terminated as of 08-03-2015 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| 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. | Terminated |
| 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. | 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. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.