FDAClass IIJanuary 29, 2014

Digoxin recall: Labeling Error

DIGOXIN, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527132401.

Why was Digoxin recalled?

Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: W002581, EXP: 6/3/2014.

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?

DIGOXIN, Tablet, 125 mcg has the following codes: Pedigree: AD76675_4, EXP: 6/3/2014.

Product
DIGOXIN, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527132401.
Recalling firm
Aidapak Services, LLC
Quantity
200 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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