FDAClass IIIDecember 17, 2014

Fluoxetine Capsules USP recall: Labeling Error

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

Why was Fluoxetine Capsules USP recalled?

Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

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 ET5122, Exp. 10/17

Product
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Recalling firm
Sandoz Incorporated
Quantity
1,008 bottles
Distribution
AZ
Recall date
December 17, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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