FDAClass IIJanuary 22, 2014

buPROPion HCl ER Tablet recall: Labeling Error

buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335073886

Why was buPROPion HCl ER Tablet recalled?

Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.

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?

buPROPion HCl ER, Tablet, 200 mg has the following code Pedigree: W002727, EXP: 6/6/2014.

Product
buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335073886
Recalling firm
Aidapak Services, LLC
Quantity
60 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls