FDA recall D-0742-2021

Product

Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed Nationwide, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2021-07-29

Report date

2021-08-25

Termination date

2024-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0742-2021