Recalls / Class II

Class IID-0570-2024

Product

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

Affected lot / code info

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

Why it was recalled

CGMP Deviations and Presence of Particulate Matter: Glass

Recalling firm

Firm

Medisca Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

6641 N Belt Line Rd Ste 130, N/A, Irving, Texas 75063-6001

Distribution

Quantity

113 bottles

Distribution pattern

Nationwide in the USA and Canada

Timeline

Recall initiated

2024-06-26

FDA classified

2024-06-28

Posted by FDA

2024-07-10

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0570-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.