Drug Enforcement D-0570-2024

CGMP Deviations and Presence of Particulate Matter: Glass

Status

Completed

Classification

Class II

Report Date

July 10, 2024

Termination Date

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Product Information

Product description
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Product quantity
113 bottles
Reason for recall
CGMP Deviations and Presence of Particulate Matter: Glass
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Canada

Location & Firm

Recalling firm
Medisca Inc.
Address
6641 N Belt Line Rd Ste 130, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0570-2024
Event ID
94868
Recall initiation date
June 26, 2024
Center classification date
June 28, 2024
Code info
Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
More code info
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