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

Recall Number: D-0988-2022

Firm: Teva Pharmaceuticals USA Inc

Classification: Class III

Status: Terminated

Report Date: 20220615

Initiation Date: 20220518

Termination Date: 20231208

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

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