ALPROSTADIL Recall D-0988-2022
Description: 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
ALPROSTADIL Recall D-0988-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0988-2022 |
| Event ID | 90239 |
| Brand | ALPROSTADIL |
| Generic Name | ALPROSTADIL |
| Manufacturer | ALPROSTADIL |
| Original Package? | 1 |
| Active Substance | ALPROSTADIL |
| Drug Route | INTRAVASCULAR |
| Distribution | Product was distributed nationwide in the US Market |
| Quantity | 3109 cartons |
| Recall Reason | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing |
| Drug Classification | Class III |
| Drug Code Info | 20220615 |
| Product NDC | 0703-1501 |
| Product NUI | N0000009059 N0000175454 N0000180189 |
| Pharma Class (PE) | Genitourinary Arterial Vasodilation [PE] |
| Pharma Class (EPC) | Prostaglandin Analog [EPC] |
| Pharma Class (CS) | Prostaglandins [CS] |
| Recall Initiation Date | 20220518 |
| Report Date | 20220615 |
| Classification Date | 20220607 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | F5TD010360 |
| Drug Application Number | ANDA075196 |
| Structured Product Labeling (SPL ID) | 85a64fab-2879-4a7b-9367-d6e7a8b5043e |
| Structured Product Labeling (SPL Set ID) | bb155759-3889-4cb3-9695-42a588f4f689 |
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