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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Medisca Budesonide Micronized Powder Recalled for Glass Particles

Agency Publication Date: June 28, 2024
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Summary

Medisca Inc. is voluntarily recalling approximately 113 bottles of Budesonide, USP (Micronized), 500 mg, which is a white to off-white odorless crystalline powder. This recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) and the confirmed presence of glass particulate matter in the medication. Because these glass fragments can cause injury, consumers should stop using the product and contact their healthcare provider or pharmacist immediately.

Risk

The presence of glass particles in a medication poses a risk of physical irritation or internal injury if consumed or administered. Additionally, manufacturing deviations mean the drug may not meet safety and quality standards.

What You Should Do

  1. The recalled product is Medisca Budesonide, USP (Micronized), 500 mg crystalline powder (NDC 38779-3097-00) with lot numbers 202323/G or 202323/H and an expiration date of 07/31/2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Medisca Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information or to report a reaction.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Budesonide, USP (Micronized) (500 mg)
Variants: 500 mg, White to off-white odorless crystalline powder
Lot Numbers:
202323/G (Exp 07/31/2026)
202323/H (Exp 07/31/2026)
NDC:
38779-3097-00

Recall #: D-0570-2024. Medisca Inc., Plattsburgh, NY, 12901, USA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94868
Status: Resolved
Manufacturer: Medisca Inc.
Sold By: Compounding pharmacies; Wholesalers
Manufactured In: United States
Units Affected: 113 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.