FDAClass IIJanuary 22, 2014

FLUoxetine HCl Capsule recall: Labeling Error

FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103

Why was FLUoxetine HCl Capsule recalled?

Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.

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?

FLUoxetine HCl, Capsule, 10 mg has the following code Pedigree: AD70585_13, EXP: 5/29/2014.

Product
FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103
Recalling firm
Aidapak Services, LLC
Quantity
100 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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