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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.
The Oct. 10 recall was of 7,107 duloxetine bottles distributed and manufactured by Towa Pharmaceutical Europe. The Nov. 19 recall is of 233,003 duloxetine bottles distributed and manufactured by ...
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 FDA recalled thousands of bottles of antidepressants after finding high levels of potentially cancer-causing chemicals. Here's what to look for.
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.
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]
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 ...