Breckenridge Pharmaceutical, Inc. is recalling 900 vials of Zoledronic Acid Injection 5 mg/100 mL, a prescription medication used for intravenous infusion. This recall was initiated because stability testing identified impurities and degradation results that were outside of the required specifications. This specific recall affects two lots of the sterile solution distributed nationwide in the United States. Consumers should not use the affected medication and should contact their healthcare provider immediately.
The presence of impurities or degradation products above the established limits can reduce the effectiveness of the drug or potentially cause unexpected side effects during intravenous administration. While the risk level is classified as low, using out-of-specification medication means the safety and quality of the drug cannot be guaranteed.
Drug recall remedy
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.