Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0988-2022
Event ID90239
BrandALPROSTADIL
Generic NameALPROSTADIL
ManufacturerALPROSTADIL
Original Package?1
Active SubstanceALPROSTADIL
Drug RouteINTRAVASCULAR
DistributionProduct was distributed nationwide in the US Market
Quantity3109 cartons
Recall ReasonFailed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Drug ClassificationClass III
Drug Code Info20220615
Product NDC0703-1501
Product NUIN0000009059 N0000175454 N0000180189
Pharma Class (PE)Genitourinary Arterial Vasodilation [PE]
Pharma Class (EPC)Prostaglandin Analog [EPC]
Pharma Class (CS)Prostaglandins [CS]
Recall Initiation Date20220518
Report Date20220615
Classification Date20220607
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
Unique Ingredient IdentifierF5TD010360
Drug Application NumberANDA075196
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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