Drug recall
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC…
FDA recall event 87452 · Class III · Teva Pharmaceuticals USA
Key facts
| Event ID | 87452 |
|---|---|
| Recall numbers | D-0309-2021 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing. |
| Initiation date | Mar 4, 2021 |
| Report date | Mar 24, 2021 |
| Termination date | May 19, 2022 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3003092769 |
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 · Source date: