FDAJune 17, 2016drug

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).

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations

What to do

FDA enforcement status: Terminated

Brands named

teva north americatevateva north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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