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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 ...
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.
A 2009 Advisory Committee to the U.S. Food and Drug Administration found that online anecdotal reports of discontinuation syndrome related to duloxetine included severe symptoms and exceeded prevalence of both paroxetine and venlafaxine reports by over 250% (although acknowledged this may have been influenced by duloxetine being a much newer ...
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.
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.
The FDA recalled thousands of bottles of antidepressants after finding high levels of potentially cancer-causing chemicals. Here's what to look for.