Eptifibatide Injection 75 mg/ single use vial recalled over manufacturing violations

Recall date

June 17, 2016

Source

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

Official notice title

Teva North America recalls Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hu…

Recall number

D-1496-2016

FDA classification

Class II

Brand / firm

Teva North America

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

CGMP Deviations

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

What was recalled

Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.