Sagent Pharmaceuticals is recalling 14,360 vials of Methylprednisolone Acetate Injectable Suspension (400 mg per 10 mL) because black particulate matter was found in the drug product. The recall affects 10 mL multi-dose vials manufactured in India and distributed nationwide to hospitals and clinics. Patients and healthcare providers should not use any product from the affected lots, as injecting foreign particles can cause serious health complications.
Injecting a drug containing foreign particles can lead to localized inflammation, the formation of granulomas, or serious systemic issues such as blood vessel blockages (embolisms) or allergic reactions. No injuries or adverse events have been reported to date, but the presence of particulates in a sterile injectable medication poses a medium risk to patient safety.
Made in India; Manufactured for Sagent Pharmaceuticals.
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 · 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.