SterRx, LLC is recalling 4,476 bags of Sodium Bicarbonate in 5% Dextrose Injection (150 mEq per 1,000 mL) due to confirmed microbial contamination found by a third-party laboratory. This recall involves 1,000 mL bags used in clinical settings that lack assurance of sterility. The product was distributed nationwide to hospitals, clinics, and pharmacies. No injuries or incidents have been reported to date.
Injecting a product contaminated with microbes can cause serious and potentially life-threatening systemic infections, such as sepsis. Because the product is intended for intravenous administration, any lack of sterility poses a critical risk to patient safety.
Recall numbers D-0767-2021 and D-0768-2021; Manufactured by SterRx, LLC in Plattsburgh, NY.
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.