The Knowledge Shelf

Joint US FDA – Health Canada ICH Public Meeting

drug recalls page, FDA’s role

Concord Biotech Limited – 04/28/2025-05/02/2025. Country: India. Record Type: 483

New Hoque & Sons Inc. of Maspeth, NY, is recalling its packages of “Dry Ghoinnya Fish” because the product was found to be uneviscerated.The recalled “Dry Ghoinnya Fish” were distributed nationwide in retail stores. The product comes in a 10-12 pound, clear plastic package marked with an expirati

The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025

Salinas, CA (October 28, 2025) – Pacific International Marketing (“Pacific”) is recalling 474 cases of bulk Italian Parsley because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with we

The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the sco

Plainview, NY. October 27, 2025— Purity Products is announcing a recall of one lot of of its dietary supplement MyBladder because it has the potential to be contaminated with Escherichia coli O7:K1 and 1303. The presence of these E. coli strains may pose a risk for gastrointestinal or other infectio

CGMP/Finished Pharmaceuticals/Adulterated

DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.