Teva Pharmaceuticals USA recalls Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648
Recalled May 7, 2014 · FDA recall D-1280-2014 · Teva Pharmaceuticals USA
Hazard
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. · FDA Class II
Units
257904 bottles
Sold at
Nationwide and Puerto Rico
Description
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →