FDAClass IIJanuary 22, 2014

Flecainide Acetate Tablet recall: Labeling Error

FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110

Why was Flecainide Acetate Tablet recalled?

Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7, EXP: 5/16/2014.

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?

FLECAINIDE ACETATE Tablet, 50 mg has the following code Pedigree: AD46414_16, EXP: 5/16/2014.

Product
FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110
Recalling firm
Aidapak Services, LLC
Quantity
100 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)
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