Drug product
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
D-0019-2025
Product summary
- Event
- Event 95427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2151 bags
- Official record key
drug-enforcement:D-0019-2025
Official wording
Reason: cGMP violations
Code information: Lot # C274-000038582, exp. date 29-Nov-24
Distribution pattern: Product was distributed to 125 direct accounts nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP violations