← FDA ENFORCEMENT
D-0570-2024Class II

Medisca Inc.

Recalling firm
Medisca Inc.
Product type
Drug
Status
Completed
Report date
2024-07-10
Distribution
Nationwide in the USA and Canada
Firm state
TX
Product quantity
113 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

CGMP Deviations and Presence of Particulate Matter: Glass

Product description

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

Code / lot info

Lot #s: 202323/G, 202323/H, Exp. 07/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.