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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

Perrigo Company PLC: Labeling: label error on declared strength.

Agency Publication Date: February 4, 2016
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Affected Products

Product: Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.

Lot #: 2015050194, Exp 2/2016

Lot Numbers:
2015050194
Product: Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157

Lot #: 2015080484, Exp 02/2016

Lot Numbers:
2015080484

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73101
Status: Resolved
Manufacturer: Perrigo Company PLC
Manufactured In: United States
Units Affected: 2 products (948 units; 918 units)

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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.