FDAClass IIJanuary 22, 2014

Galantamine HBR ER Capsule recall: Labeling Error

GALANTAMINE HBR ER Capsule, 24 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335083783

Why was Galantamine HBR ER Capsule recalled?

Labeling: Label Mixup; GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESCITALOPRAM, Tablet, 5 mg, NDC 00093585001, Pedigree: W003733, EXP: 6/26/2014.

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?

GALANTAMINE HBR ER, Capsule, 24 mg has the following code Pedigree: W003735, EXP: 5/31/2014.

Product
GALANTAMINE HBR ER Capsule, 24 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335083783
Recalling firm
Aidapak Services, LLC
Quantity
30 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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