Drug recall
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous…
FDA recall event 77731 · Class III · Pfizer Inc.
Key facts
| Event ID | 77731 |
|---|---|
| Recall numbers | D-0001-2018 |
| Recalling firm | Pfizer Inc. |
| Product type | Drugs |
| Products | Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Firm failed to control impurity for color change at the API stage. |
| Initiation date | Jul 12, 2017 |
| Report date | Oct 11, 2017 |
| Termination date | Jul 16, 2020 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 2416101 |
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 · Source date: