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Is there a 2024 Duloxetine antidepressant drug recall by the FDA? Yes, the FDA noted the medication had the "presence" of nitrosamine drug substance impurity, N-nitroso-duloxetine.
The FDA recalled thousands of bottles of antidepressants after finding high levels of potentially cancer-causing chemicals. Here's what to look for.
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.
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 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 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 recommends these ...
The Food and Drug Administration announced a Class II recall for more than 7,000 bottles of an antidepressant due to a chemical.. The recall was initiated earlier this month on Oct. 10. Duloxetine ...