FDAClass IIJanuary 29, 2014

Mexiletine HCL recall: Labeling Error

MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093873901.

Why was Mexiletine HCL recalled?

Labeling: Label Mixup: MEXILETINE HCL, Capsule, 150 mg may have potentially been mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62865_4, EXP: 5/23/2014.

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?

MEXILETINE HCL, Capsule, 150 mg has the following codes: Pedigree: AD62865_7, EXP: 5/23/2014.

Product
MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093873901.
Recalling firm
Aidapak Services, LLC
Quantity
100 Capsules
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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