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 PHARMAC
Recalled September 14, 2016 · FDA recall D-1494-2016 · Teva North America
Hazard
CGMP Deviations · FDA Class II
Units
1,299 bags
Sold at
Nationwide and Puerto Rico
Description
CGMP Deviations
Product
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).
Manufacturer(s)
Teva North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →