FDA-Drug2015-05-06Class II
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960
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.
Sold states
Nationwide
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0971-2015Don't want to check this manually?
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