Recalls / Class II
Class IID-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.
- Brand name
- Fluoxetine
- Generic name
- Fluoxetine
- Active ingredient
- Fluoxetine Hydrochloride
- Route
- Oral
- NDCs
- 50111-647, 50111-648
- FDA application
- ANDA076001
- Affected lot / code info
- 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
Why it was recalled
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 257904 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-02-12
- FDA classified
- 2014-04-28
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1280-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.