Teva Pharmaceuticals USA recalls Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A.,
Recalled May 6, 2015 · FDA recall D-0970-2015 · Teva Pharmaceuticals USA
Hazard
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. · FDA Class II
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Description
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.
Product
Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →