FDAFDA · Food and drugs·Recall number D-1494-2016
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).
Published September 14, 2016 · Recall initiated: June 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva North America
- Distributor
- Nationwide and Puerto Rico
- Lot
- All lots within Expiry. Lot # 4720915, 6790315, 6800315, 6810315, 6820315
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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