Drug product
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
D-0570-2024
Product summary
- Firm
- Medisca Inc.
- Event
- Event 94868
- Status
- Completed
- Classification
- Class II
- Quantity
- 113 bottles
- Official record key
drug-enforcement:D-0570-2024
Official wording
Reason: CGMP Deviations and Presence of Particulate Matter: Glass
Code information: Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
Distribution pattern: Nationwide in the USA and Canada
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter
-
Manufacturing or process control
CGMP Deviations