FDA-Drug2022-06-15Class III
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
Teva Pharmaceuticals USA Inc
Hazard
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Sold states
Product was distributed nationwide in the US Market
Affected count
3109 cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0988-2022Don't want to check this manually?
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