FDA recall D-0274-2021

Product

Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.

Reason for recall

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Distribution

Product was distributed nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2021-02-10

Report date

2021-03-03

Termination date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0274-2021