FDA-Drug2016-09-14Class II

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.

Teva North America
Hazard

CGMP Deviations

Sold states
Nationwide and Puerto Rico
Affected count
14,661 vials
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
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.

Official notice

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

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