FDA (Drugs) recall action 70976
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
The agency’s own wording, quoted from the enforcement report.
Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules 10 mg due to an elevated level of a residual solvent impurity in the active ingredient.
Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules USP, 20 mg, due to an elevated level of a residual solvent impurity in the active pharmaceutical ingredient.