Reported May 7, 2014 · Terminated
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 100-count bottles (NDC 50111-648-01) |
| 2 | 500-count bottles (NDC 50111-648-02) |
| 3 | 1000-count bottles (NDC 50111-648-03), and |
| 4 | 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. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15 2 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15 3 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15 4 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15 - Amount recalled
- 257904 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
This product could cause temporary or reversible health problems — stop using it.
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