Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12
Summary
The FDA issued a Class II for Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p by Medisca Inc.. Reason: CGMP Deviations and Presence of Particulate Matter: Glass.
Details
Source
Drug Recall
External ID
D-0570-2024
Action Date
2024-07-10
Status
Completed
Category
drug
Product Description
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Lot/Code Info: Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
Quantity Affected: 113 bottles
Reason for Recall
CGMP Deviations and Presence of Particulate Matter: Glass
Distribution
Nationwide in the USA and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-26
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 53 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Medisca Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medisca Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medisca Inc. have FDA actions?
Medisca Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0570-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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