FDA Recall D-0040-2025
Staska Pharmaceuticals, Inc. · Bennet, NE
Class I — life-threatening Terminated 309 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Reason for recall
Presence of Particulate Matter: Presence of glass particulates.
Recall record
- Recall number
D-0040-2025- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-09-30
- Classified by FDA Center
- 2024-11-07
- FDA published
- 2024-11-13
- Terminated
- 2025-08-05
- Recalling firm
- Staska Pharmaceuticals, Inc.
- Firm location
- Bennet, NE