Drug recall
Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/650 mg, 1000 tablets per bottle, Rx only, NDC…
FDA recall event 35474 · Class III · IVAX Pharmaceuticals
Key facts
| Event ID | 35474 |
|---|---|
| Recall numbers | D-269-6 |
| Recalling firm | IVAX Pharmaceuticals |
| Product type | Drugs |
| Products | Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/650 mg, 1000 tablets per bottle, Rx only, NDC 0172-4980-80, IVAX Pharmaceuticals, Inc., Miami, FL 33137 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed dissolution test requirements |
| Initiation date | May 4, 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