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.