FDAFDA · Food and drugs·Recall number D-0971-2015
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
Published May 6, 2015 · Recall initiated: April 13, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUOXETINE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide
- Lot
- Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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