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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
These changes caused drugs made with tetrazole to be contaminated with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which cause genetic damage and cancer. [20] This contamination was not detected until 2018. The incident, according to medicinal chemist and pharmaceutical industry blogger Dr. Derek Lowe, points to a greater ...
Pharmaceutical recalls skyrocketed to 517 events in 2023 compared to 363 the year before, a 42.4% increase, according to Sedgwick’s State of the Nation 2024 Product Safety and Recall report ...
Think before you drink. The FDA has recalled 28 beverages so far in 2024, The Daily Mail reported. All but four of the drinks were recalled because they had drugs, bacteria or harmful chemicals in ...
Old logo (1972-2018) The United States Consumer Product Safety Commission (USCPSC, CPSC, or commission) is an independent agency of the United States government.The CPSC seeks to promote the safety of consumer products by addressing "unreasonable risks" of injury (through coordinating recalls, evaluating products that are the subject of consumer complaints or industry reports, etc ...
The FDA's decision came as a surprise to company officials and many Alzheimer's experts, who had expected a full approval for Lilly's drug donanemab this month based on clinical trial data last ...