FDAFDA · Food and drugs·Recall number D-1281-2014
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Published May 7, 2014 · Recall initiated: February 12, 2014
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: Recall due to a customer complaint trend regarding capsule odor.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUOXETINE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide and Puerto Rico
- UPC
- 350111647015
- Lot
- Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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