Drug recall D-1280-2014
Product
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Reason for recall
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Lots and codes
Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Quantity
- 257904 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.