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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 ...
More than 233,000 bottles of an antidepressant have been recalled by the FDA due to the presence of duloxetine posing the risk of cancer. ... The Oct. 10 recall was of 7,107 duloxetine bottles ...
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 ...
Duloxetine is acid labile, and is formulated with an enteric coating to prevent degradation in the stomach. Duloxetine has good oral bioavailability, averaging 50% after one 60 mg dose. [9] There is an average 2-hour lag until absorption begins with maximum plasma concentrations occurring about 6 hours post-dose.
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.
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 Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
The Food and Drug Administration (FDA) issued a Class II recall of more than 7,100 bottles of the antidepressant duloxetine due to the possible presence of a carcinogen. Duloxetine belongs to a ...