FDA recall D-1494-2016

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).

Reason for recall

CGMP Deviations

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-06-17

Report date

2016-09-14

Termination date

2017-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1494-2016