Alprostadil Injection USP 500 mcg/mL — Class III drug recall D-0988-2022
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2022-06-15, distributed nationwide. Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during rout
| Recall number | D-0988-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2022-05-18 |
| Classified | 2022-06-07 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2023-12-08 |
| Distributed | Nationwide (US) |
| Quantity | 3,109 cartons |
| Reason classes | specification failure |
| NDC | 00703-1501-01, 00703-1501-02 |
| Lot numbers | 100022404, 100023333 |
| Expiration dates | 2022-10 |
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 for recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0988-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.