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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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Medium RiskFDA Drug

Novartis Consumer Health: CGMP Deviations: Potential for the bottles to contain foreign tablets or broken/chipped tablets; lack of cGMP's.; Potential for the bottles to contain foreign tablets or broken/chipped tablets; lack of cGMP's; CGMP Deviations: Potential for the bottles to contain foreign tablets or broken/chipped tablets; lack of cGMP's

Agency Publication Date: February 21, 2012
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 60840
Status: Resolved
Manufacturer: Novartis Consumer Health
Manufactured In: United States
Units Affected: 21 products (254,448 bottles; 197,280 bottles; 1,069,176 bottles; 6,360,060 bottles; 13,945,404 bottles; 6,058,425 bottles; 495,648 bottles; 28,055,379 bottles; 1,611,864 bottles; 25,959,584 bottles; 7,678,248 bottles; 5,667,504 bottles; 799,596 bottles; 2,011,932 bottles; 7,166,220 bottles; 1,015,536 bottles; 6,058,860 bottles; 1,853,784 bottles; 276,264 bottles; 1,599,804 bottles; 5,856,816 bottles)

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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.