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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

Guardian Drug Co. Inc.: Microbial Contamination of Non-Sterile Product: Simethicone containing products may be contaminated with B. cepacia due to a raw material that was used to manufacture the product.

Agency Publication Date: April 3, 2012
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 61371
Status: Resolved
Manufacturer: Guardian Drug Co. Inc.
Manufactured In: United States
Units Affected: 13 products (155472 cartons; 9744 cartons; 125,856 cartons; 50088 cartons; 19,296 cartons; 38,340 cartons; 343,368 units; 936 cartons; 5,112 cartons; 183,228 cartons; 22,560 units; 36,000 units; 125856 cartons)

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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.