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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

Glenmark Pharmaceuticals Inc. USA: Failed Impurity Specificiation Measured value for relates substances unknown impurity and total impurities have exceeded specification at 3 month stability timepoint.; Measured value for relates substances unknown impurity and total impurities have exceeded specification at 3 month stability timepoint.

Agency Publication Date: March 25, 2009
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 50527
Status: Resolved
Manufacturer: Glenmark Pharmaceuticals Inc. USA
Manufactured In: United States
Units Affected: 2 products (15 g: 39,696 tubes; 45 g: 21,792 tubes; 15 g: 11616 tubes; 45 g: 9072 tubes.)

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.