Report: FDA strengthens monitoring of post-approval drug safety

A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.

XROCK INDUSTRIES, LLC Issues a Voluntary Nationwide Recall of X-ROCK, a Product Marketed as a Dietary Supplement To Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient

XROCK INDUSTRIES, an independent distributor of the X-ROCK products, is conducting a user level voluntary recall of certain supplement products sold by XROCK INDUSTRIES under the brand name of X-ROCK. Finished product of X-ROCK for Men was tested and preliminarily found to contain an analogue of an ingredient in an FDA-approved drug.

Hong Lee Trading Inc. Issues An Alert On Undeclared Sulfites In Peacock Brand Preserved Apricots

Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203 is recalling Peacock Brand Preserved Apricots because it may contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
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M.E. Thompson, Inc. Expands Recall of Sub Sandwiches Because of Possible Health Risk

M.E. Thompson, Inc. is expanding the recall of its Anytime Deli Turkey & Ham Footlong, to include Italian Footlong, and Classic Cuban, because the products have the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.