FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.

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:

CGMP/Finished Pharmaceuticals/Adulterated

Shang Hao Jia, Inc. of South El Monte, CA is recalling 50 case of Danshi brand Spicy Shredded Tofu, because it may contains undeclared sesame.

Clinical projects of the Oncology Center of Excellence, 2023 Annual Report

Zingerman’s Candy Manufactory of Ann Arbor, Michigan is recalling Zingerman’s Peanut Butter Crush Full Size Bars with Lot#174250 because it may contain undeclared cashew and Zingerman’s Ca$hew Cow Full Size Bars with Lot#174250 because it may contain undeclared peanut. People who have an allergy or