Drug product
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
D-1497-2016
Product summary
- Event
- Event 74497
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,223 vials
- Official record key
drug-enforcement:D-1497-2016
Official wording
Reason: CGMP Deviations
Code information: All Lots Within Expiry Lot # 2930614, 2940614, 2950614
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations