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The recall covers 7,107 bottles of duloxetine, the FDA said. The bottles include 500 delayed-release 20mg capsules. The lot number is 220128, with an expiration date of 12/2024.
The U.S. Food and Drug Administration announced a Class II recall for more than 7,100 bottles of Duloxetine — a generic antidepressant for Cymbalta — due to a cancerous chemical.. A voluntary ...
The FDA has recalled thousands of bottles of the antidepressant duloxetine, sold under brand name Cymbalta, due to the presence of a possibly cancer-causing chemical.
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 incident, according to medicinal chemist and pharmaceutical industry blogger Dr. Derek Lowe, points to a greater problem. Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be more widespread and undetected in generic drugs ...
The 2022–2023 United States Pseudomonas aeruginosa outbreak began in May 2022, with the infection of several patients in California. The Centers for Disease Control and Prevention (CDC) became aware of a strain of Pseudomonas aeruginosa in artificial tears manufactured by EzriCare and Delsam Pharma in January 2023.
The company's share price has fallen nearly 20% since Friday when it first issued a voluntary recall of its own supplements. On Wednesday, they closed down 3.8% at 4,875 yen.
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