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FDAApril 13, 2015drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

teva pharmaceuticalsteva

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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