June 2024 FDA Recall Drug by Medisca Inc.
D-0570-2024 - CGMP Deviations and Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Medisca Inc. on June 26, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations and presence of particulate matter. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0570-2024

Reason for Recall
CGMP Deviations and Presence of Particulate Matter: Glass
Initiated
06-26-2024
Reported
07-10-2024
Quantity
113 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94868
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medisca Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Canada
Product Description About Product Description
Full technical description of the product.
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

Batch or Lot Expiration Information

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