Drug product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
D-0016-2025
Product summary
- Event
- Event 95427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2756 bags
- Official record key
drug-enforcement:D-0016-2025
Official wording
Reason: cGMP violations
Code information: Lot #C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24
Distribution pattern: Product was distributed to 125 direct accounts nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP violations