FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors
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As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.GDUFA Paid Facilities List
This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:One Frozen, LLC Voluntarily Recalls Good & Gather™ Southwest Style Burrito Bowl Blend, Frozen, 12oz Bags Due to Undeclared Shrimp Allergen
One Frozen, LLC of Rochester, NY, is voluntarily recalling certain lots of Good & Gather™ Southwest-Style Burrito Bowl Blend (frozen, 12oz bags) because the product may contain shrimp (crustacean shellfish) that was not declared on the ingredient label of the product. People who have an allergy orUBI Pharma Inc. – 10/14/2025
UBI Pharma Inc. – 10/14/2025Medinatura New Mexico, Inc. – 716025 – 12/10/2025
CGMP/Finished Pharmaceuticals/AdulteratedApotex Inc. – 714137 – 10/31/2025
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