Drug recall
FazaClo (clozapine, USP) Orally Disintegrating Tablets 100 mg, each tablet packaged in a child-resistant…
FDA recall event 44935 · Class II · AZUR PHARMA INC
Key facts
| Event ID | 44935 |
|---|---|
| Recall numbers | D-003-2008 |
| Recalling firm | AZUR PHARMA INC |
| Product type | Drugs |
| Products | FazaClo (clozapine, USP) Orally Disintegrating Tablets 100 mg, each tablet packaged in a child-resistant blister, 100 tablets per box, NDC 68322-002-04, RX, Manufactured for Alamo Pharmaceuticals… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mispacked; Non child-resistant blister packages were packaged in boxes labeled as child-resistant. |
| Initiation date | Sep 19, 2007 |
| Termination date | Oct 7, 2008 |
| City | EXTON |
| State | PA |
| Country | United States |
| FEI number | 3006475714 |
At a glance
- 1–9 Products in this recall
- None 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