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 USASellersvillePA 18960NDC 50111-647-01UPC 3 50111-647-01 5
- Lot codes and dates
Lot #: 6A2111586A2111596A211163Exp 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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