Teva Pharmaceuticals USA recalls Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA…

Recall date

September 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0244-2019

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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