FDA-Drug2014-05-07Class II
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Teva Pharmaceuticals USA
Hazard
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Sold states
Nationwide and Puerto Rico
Affected count
72,356 bottles
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2014Don't want to check this manually?
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