FDA Recall Hydroxyzine Pamoate
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Hydroxyzine Pamoate with NDC 0555-0323 was initiated on 01-24-2014 as a Class II recall due to cgmp deviations: hydroxyzine pamoate capsules, usp, 100 mg were manufactured using an unapproved material: api was incorrectly released for use in manufacturing. The latest recall number for this product is D-1093-2014 and the recall is currently terminated as of 10-08-2014 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1093-2014 | 01-24-2014 | 03-12-2014 | Class II | 2494 capsules | Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 | Terminated |
| D-1095-2014 | 01-24-2014 | 03-12-2014 | Class II | 35746 capsules | Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02. | 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.