Cipla is recalling 641,160 ampules of Budesonide (budesonide) Inhalation Suspension 0.25mg/2mL due to a lack of sterility assurance. Sterility is critical for inhaled medications; if the product is contaminated, it could lead to respiratory or other systemic infections. No injuries or illnesses have been reported to date in connection with this recall.
The lack of sterility assurance means the manufacturer cannot guarantee the medication is free from bacteria or other microorganisms. Inhaling non-sterile medication directly into the lungs poses a significant risk of infection, especially for individuals with compromised immune systems or underlying respiratory conditions.
You have 2 options:
Packaged as 1 envelope x five 2 mL ampules per pouch; Manufactured by Cipla Ltd., India for Cipla USA Inc.
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.
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.