Drug 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).
D-1494-2016
Product summary
- Event
- Event 74497
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,299 bags
- Official record key
drug-enforcement:D-1494-2016
Official wording
Reason: CGMP Deviations
Code information: All lots within Expiry. Lot # 4720915, 6790315, 6800315, 6810315, 6820315
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations