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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 ...
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All U.S. employees have been laid off after the company declared Chapter 7 bankruptcy.
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 ...
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]
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.
Consumers who may have bought the recalled products or who have questions can contact SunFed's recall hotline at (888) 542-5849, Monday through Friday from 8 a.m. to 5 p.m. Mountain Time.
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