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FDAMay 18, 2022drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

teva pharmaceuticalsteva

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 Details · AllClear