Class II
Terminated
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
This recall has been terminated (originally issued May 6, 2015).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- April 13, 2015
- Posted
- May 6, 2015
- Recall Number
- D-0971-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015.
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