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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

Shamrock Medical Solutions Group LLC: Marketed Without an Approved NDA/ANDA: Split tablets distributed as an unapproved new drug

Agency Publication Date: November 9, 2010
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 55906
Status: Resolved
Manufacturer: Shamrock Medical Solutions Group LLC
Manufactured In: United States
Units Affected: 32 products (193 tablets; 316 tablets; 18 tablets; 532 tablets; 1131 tablets; 871 tablets; 117 tablets; 194 tablets; 1029 total tablets; 1923 tablets; 416 tablets; 218 tablets; 2689 tablets; 51441 tablets; 1779 tablets; 318 tablets; 1731 tablets; 364 tablets; 192 tablets; 174 tablets; 5904 tablets; 752 tablets; 1557 tablets; 796 tablets; 195 tablets; 1537 tablets; 417 tablets; 199 tablets; 398 tablets; 953; 194; 149)

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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.