FDAClass IIJanuary 22, 2014

Isometheptene Mucate/ Dichloralphenazone/apap Capsule recall: Labeling Error

ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001

Why was Isometheptene Mucate/ Dichloralphenazone/apap Capsule recalled?

Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially mislabeled as ALBUTEROL SULFATE ER, Tablet, 4 mg, NDC 00378412201, Pedigree: W003578, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD22616_7, EXP: 5/2/2014.

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?

ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg has the following codes Pedigree: W003596, EXP: 5/31/2014; Pedigree: AD22858_1, EXP: 3/31/2014.

Product
ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001
Recalling firm
Aidapak Services, LLC
Quantity
200 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)
Open FDA enforcement record Latest recalls