Dr. Reddy's Laboratories, Inc. is voluntarily recalling 69,998 vials of Zoledronic Acid Injection, 5mg/100 mL, including those under the NOVAPLUS brand name. This recall was initiated because the medication failed to meet impurity and degradation specifications during testing, meaning unknown substances were found in the vials that should not be there. This prescription drug was distributed to retailers, distributors, medical facilities, and physician offices across the United States between 2018 and 2020.
The presence of unknown impurities or degradation products in an injectable medication may lead to unexpected side effects or reduced effectiveness of the treatment. While the risk level is currently categorized as low, impurities in an intravenous drug bypass the body's natural defenses and can cause adverse reactions.
Healthcare guidance and product refund.
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
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