Drug recall
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC…
FDA recall event 90239 · Class III · Teva Pharmaceuticals USA Inc
Key facts
| Event ID | 90239 |
|---|---|
| Recall numbers | D-0988-2022 |
| Recalling firm | Teva Pharmaceuticals USA Inc |
| Product type | Drugs |
| Products | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing |
| Initiation date | May 18, 2022 |
| Report date | Jun 15, 2022 |
| Termination date | Dec 8, 2023 |
| 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: