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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

Novartis Consumer Health: Presence of Foreign Substance; a small amount of non-USP water leaked into the batches due to a seal breach on a pump

Agency Publication Date: January 11, 2012
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 59834
Status: Resolved
Manufacturer: Novartis Consumer Health
Manufactured In: United States
Units Affected: 4 products (200,508/12-fl. oz. bottles; 20,460 bottles; 20,160/350-mL bottles; 91,656/150-ml. btls and 83,292/250-ml. btls)

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.