Drug product
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
D-1043-2018
Product summary
- Event
- Event 80638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 230 Intravia Bags
- Official record key
drug-enforcement:D-1043-2018
Official wording
Reason: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Code information: Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Manufacturing or process control
CGMP deviations