FDA-Drug2014-05-07Class II
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.
Teva Pharmaceuticals USA
Hazard
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Sold states
Nationwide and Puerto Rico
Affected count
257904 bottles
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1280-2014Don't want to check this manually?
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