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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

Able Laboratories Inc.: Mislabeled due to non compliance with 21 CFR201.24.

Agency Publication Date: April 1, 2005
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 31089
Status: Active
Manufacturer: Able Laboratories Inc.
Manufactured In: United States
Units Affected: 4 products (NDC 53265-353-05 -21306 bottles; NDC Code 53265-374-10- 12804 bottles; NDC Code 53265-374-50- 12,206 bottles; NDC Code 53265-374-70 - 3838 bottles.; NDC Code 53265-375-10 - 5221 bottles; NDC Code 53265-375-50 - 13583 bottles; NDC Code 52365-375-60 -118,781 bottles; NDC Code 53265-353-05 - 25314 bottles)

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.