FDA recall D-1496-2016

Teva North America · Class II · drug

Product

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.

Reason for recall

CGMP Deviations

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-06-17
Report date: 2016-09-14
Termination date: 2017-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1496-2016