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.

Recall Number: D-1281-2014

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20140507

Initiation Date: 20140212

Termination Date: 20141215

Reason for Recall

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

Product Description

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.