Drug product
Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
D-1495-2016
Product summary
- Event
- Event 74497
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92,480 containers
- Official record key
drug-enforcement:D-1495-2016
Official wording
Reason: CGMP Deviations
Code information: All Lots Within Expiry
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations