FDA recall D-0988-2022

Product

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

Reason for recall

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

Distribution

Product was distributed nationwide in the US Market

Key facts

Status

Terminated

Initiation date

2022-05-18

Report date

2022-06-15

Termination date

2023-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0988-2022