FDA Drug recall D-0244-2019
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales,…
- FDA Drug
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales,… 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-0244-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-27 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Reason
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Identifiers
| code_info | Lot # 31323147B, exp. date 01/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-04-15 · Teva Pharmaceuticals Usa
All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0244-2019%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.