Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

FDA recall notice · announced July 10, 2024 · Medisca

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

Reason for recall

CGMP Deviations and Presence of Particulate Matter: Glass

Notes

Distribution: Nationwide in the USA and Canada
Lot/code information: Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
Quantity: 113 bottles
Status: Completed
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.