Drug product
Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
D-1496-2016
Product summary
- Event
- Event 74497
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,661 vials
- Official record key
drug-enforcement:D-1496-2016
Official wording
Reason: CGMP Deviations
Code information: All Lots Within Expiry Lot# 2710715, 2720715, 2730715, 3110715, 3120715
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations