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Showing 661–680 of 29086 results

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LX Bioboost Plus (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

LL Bioboost Injectable (Thrive Health Solutions) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

NAD+ Injectable (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Semaglutide/Cyanocobalamin Injectable (Thrive Health Solutions) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Semaglutide (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Tirzepatide Injections (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Tirzepatide Injections (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Semaglutide (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Tirzepatide Injections (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Creamy Avocado Spicy Salsa (Pain Train) – undeclared milk (2025)

Undeclared Allergen

Undeclared Milk Allergen

Class IIModerate

FDAMay 21, 2025TX• Pain Train Salsa, LLC

Raspberry Croissant (Element 112) – Undeclared Wheat (2025)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAMay 16, 2025IN, MI, OH• Element 112, LLC

Chocolate Croissant (Element 112) – Undeclared Wheat (2025)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAMay 16, 2025IN, MI, OH• Element 112, LLC

Butter Croissant Bun (Element 112) – Undeclared Wheat (2025)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAMay 16, 2025IN, MI, OH• Element 112, LLC

Theophylline Extended-Release Tablets (Glenmark) – Dissolution Test Failure (2025)

OOS results reported for the Dissolution (by UV) test.

Class IIModerate

FDAMay 15, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Indomethacin Extended-Release Capsules (Amerisource) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 15, 2025Nationwide• Amerisource Health Services LLC

BD ChloraPrep Clear (CareFusion) – Packaging Seal Issue (2025)

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Class IIModerate

FDAMay 15, 2025Nationwide• CareFusion 213, LLC

Airsupra Inhalation Aerosol (AstraZeneca) – Delivery System Defect (2025)

Defective delivery system

Class IIModerate

FDAMay 14, 2025Nationwide• AsttraZeneca Pharmaceuticals LP

Dal Garlic Rice Mix (NatureMills) – Milk and Wheat (2025)

Undeclared Allergen

Undeclared milk and wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Sesame Rice Mix (NatureMills) – Undeclared Milk (2025)

Undeclared Milk

Undeclared milk

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Traditional Sambar Powder (NatureMills) – Multiple Allergens (2025)

Undeclared Allergen

Undeclared sesame and wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

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