FDAClass IIMay 7, 2014

Fluoxetine Capsules USP recall: Contamination

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

Why was Fluoxetine Capsules USP recalled?

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15

Product
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland…
Recalling firm
Teva Pharmaceuticals USA
Quantity
72,356 bottles
Distribution
Nationwide and Puerto Rico
Recall date
May 7, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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