Drug 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.
D-1281-2014
Product summary
- Event
- Event 67563
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72,356 bottles
- Official record key
drug-enforcement:D-1281-2014
Official wording
Reason: Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Code information: Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination