PDUFA Performance Reports

A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0

Compounding Pharmacy/Adulterated Drug Products

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Abdallah Candies is voluntarily recalling a specific lot of Pecan Caramel Clusters, due to a mislabeled allergen. Product contains Cashews that were not listed on the product label. Product was sold and distributed exclusively to Lunds & Byerlys, as a private label, sold in the state of Minnesota.

CGMP/Finished Pharmaceuticals/Adulterated

Tropicale Foods of Ontario, CA is recalling certain Helados Mexico and La Michoacana products with specific best by dates, as detailed below because these products contain undeclared milk.