Drug recall D-1281-2014
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 for recall
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Lots and codes
Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Quantity
- 72,356 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 12, 2014
- Terminated
- December 15, 2014
Related products
- Fluoxetine – drug information
- NDC 50111-648 Fluoxetine · Fluoxetine Hydrochloride 20 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 50111-647 Fluoxetine · Fluoxetine Hydrochloride 10 mg/1 · Teva Pharmaceuticals USA, Inc.