FDA Drug recall D-0988-2022
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 Pha…
- FDA Drug
- Class III
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class III recall of 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 Pha… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0988-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-05-18 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
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 0703-1501-01
Reason
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Identifiers
| code_info | Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0988-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.