Drug recall
FLUOXETINE CAPSULES USP, 10mg, 100 count bottles (Aqua Blue/White), Rx Only, Manufactured by IVAX…
FDA recall event 27755 · Class III · IVAX Pharmaceuticals Inc
Key facts
| Event ID | 27755 |
|---|---|
| Recall numbers | D-077-4 |
| Recalling firm | IVAX Pharmaceuticals Inc |
| Product type | Drugs |
| Products | FLUOXETINE CAPSULES USP, 10mg, 100 count bottles (Aqua Blue/White), Rx Only, Manufactured by IVAX Pharmaceuticals, Inc, Miami, FL 33137, NDC 0172-4363-60 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities; Total Impurity level exceeded (12 month) |
| Initiation date | Nov 6, 2003 |
| Termination date | Apr 15, 2004 |
| City | Northvale |
| Country | United States |
| FEI number | 2219541 |
At a glance
- 1–9 Products in this recall
- 10–99 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