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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

Bausch & Lomb, Inc.: Lack of Assurance of Sterility: Bausch & Lomb initiated a recall of Soothe Xtra Protection (XP) eye drops due to testing which showed specific lots of the product were trending out of specification for preservative efficacy prior to their listed date of shelf-life. Soothe Xtra Protection (XP) may not provide sufficient protection against inadvertent microbial contamination during storage and usag

Agency Publication Date: November 10, 2011
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 60213
Status: Resolved
Manufacturer: Bausch & Lomb, Inc.
Manufactured In: United States
Units Affected: 2 products (1,731,225 bottles; 2,772,336 bottles)

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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.