FDA recall D-0244-2019

Product

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02

Reason for recall

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

Distribution

Product was distributed throughout the United States, including Hawaii and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-09-27

Report date

2018-11-21

Termination date

2020-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0244-2019