Class II
Terminated
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland 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 7, 2014).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 12, 2014
- Posted
- May 7, 2014
- Recall Number
- D-1280-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 257904 bottles
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15
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