Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development – 05/29/2024

CGMP/Finished Pharmaceuticals/Adulterated

Sabores Fit Bakery of Kissimmee, FL is recalling MOUSSE DESSERTS, because they may contain undeclared Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts ( Almonds, Hazelnuts ). People who have an allergy or severe sensitivity to these allergens run the risk of serio

Unapproved New Drugs/Misbranded

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.

Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

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