Home / Recalls / Teva North America / D-1494-2016

D-1494-2016 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: 1,299 bags

Product Description

ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).

Reason for Recall

CGMP Deviations

Distribution Pattern

Nationwide and Puerto Rico

Code Information

All lots within Expiry. Lot # 4720915, 6790315, 6800315, 6810315, 6820315

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