FDAClass IIJanuary 22, 2014

Galantamine Hbr ER recall: Labeling Error

GALANTAMINE HBr ER, Capsule, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147089103

Why was Galantamine Hbr ER recalled?

Labeling: Label Mixup; GALANTAMINE HBr ER, Capsule, 8 mg may be potentially mislabeled as FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003508, EXP: 6/21/2014.

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, 8 mg has the following code Pedigree: W003509, EXP: 6/21/2014.

Product
GALANTAMINE HBr ER, Capsule, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147089103
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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