Recall: D-1281-2014

Class II - Potentially Harmful

Class IIClassification

2014-02-12Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

Product

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.

Reason

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.