D-1496-2016 Class II Terminated

Recalled by Teva North America — Horsham, PA

Recall Details

Product Type
Drugs
Report Date
September 14, 2016
Initiation Date
June 17, 2016
Termination Date
February 7, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,661 vials

Product Description

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 Pattern

Nationwide and Puerto Rico

Code Information

All Lots Within Expiry Lot# 2710715, 2720715, 2730715, 3110715, 3120715