ARGATROBAN Injection in 0 recalled over manufacturing violations

Recall date

June 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teva North America recalls ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMA…

Recall number

D-1494-2016

FDA classification

Class II

Brand / firm

Teva North America

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).