FDA recall D-0570-2024

Medisca Inc. · Class II · drug

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

Distribution

Nationwide in the USA and Canada

Key facts

Status
Completed
Initiation date
2024-06-26
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2024