American Regent, Inc. has issued a voluntary recall for 4,136 cartons of Nicardipine Hydrochloride Injection, USP (25 mg/10 mL), distributed under the Civica brand. This prescription medication, which is administered intravenously to treat high blood pressure, was found to have a lack of assurance of sterility. Because the sterility of the vials cannot be guaranteed, using this product could introduce contaminants directly into a patient's bloodstream.
The use of a non-sterile injectable medication poses a significant health risk, as it may lead to serious or life-threatening systemic infections, such as sepsis. No injuries or adverse events have been reported to date in connection with this recall.
Manufacturer-initiated return of clinical supply.
Manufactured for Civica, Inc. by American Regent, 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 · Raw API Response
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