FDAClass IIJanuary 29, 2014

Digoxin recall: Labeling Error

DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.

Why was Digoxin recalled?

Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD21846_34, EXP: 5/1/2014; DESMOPRESSIN ACETATE, Tablet, 0.1 mg, NDC 00591246401, Pedigree: AD46426_16, EXP: 5/15/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: AD60264_1, EXP: 5/22/2014; LIOTHYRONINE SODIUM,

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, 0.125 mg has the following codes: Pedigree: AD22609_4, EXP: 4/30/2014; Pedigree: AD46426_22, EXP: 5/15/2014; Pedigree: AD62829_8, EXP: 5/23/2014; Pedigree: W003154, EXP: 6/13/2014.

Product
DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.
Recalling firm
Aidapak Services, LLC
Quantity
400 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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