Drug product
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
D-0040-2025
Product summary
- Event
- Event 95503
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4773 vials
- Official record key
drug-enforcement:D-0040-2025
Official wording
Reason: Presence of Particulate Matter: Presence of glass particulates.
Code information: Lot #SP2400058, Exp 12/31/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter