Drug product
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
D-1044-2018
Product summary
- Event
- Event 80638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450 Syringes
- Official record key
drug-enforcement:D-1044-2018
Official wording
Reason: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Code information: Lot 181730039D, Exp 09/20/2018
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Manufacturing or process control
CGMP deviations