Drug recall
Hydroxyzine Pamoate 25mg Capsules, USP, Rx only, 500 capsules, Manufactured by: IVAX Pharmaceuticals, Inc…
FDA recall event 35812 · Class II · IVAX Pharmaceuticals
Key facts
| Event ID | 35812 |
|---|---|
| Recall numbers | D-338-6 |
| Recalling firm | IVAX Pharmaceuticals |
| Product type | Drugs |
| Products | Hydroxyzine Pamoate 25mg Capsules, USP, Rx only, 500 capsules, Manufactured by: IVAX Pharmaceuticals, Inc., Miami, FL 33137, NDC 0172-2911-70 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: For products and/or lots, unidentified extraneous peaks were noted at chromatographic analysis. Chromatographic analysis of extraneous peaks was determined to be… |
| Initiation date | Jun 26, 2006 |
| Termination date | May 27, 2011 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3002047518 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports