Reported May 7, 2014 · Terminated

Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical…

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?

  • Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only
  • Manufactured in Poland ByPliva 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
Lot codes and dates
    • Lot #: 6A211158
    • 6A211159
    • 6A211163
    • Exp 11/15
Amount recalled
72,356 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 15, 2014 · Data as of Sep 19, 8:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.