FDAClass IIJanuary 29, 2014

Sotalol HCL recall: Labeling Error

SOTALOL HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106001.

Why was Sotalol HCL recalled?

Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the following drug: NEOMYCIN SULFATE, Tablet, 500 mg, NDC 51991073801, Pedigree: AD49448_17, EXP: 5/17/2014.

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?

SOTALOL HCL, Tablet, 120 mg has the following codes: Pedigree: AD49448_20 EXP: 5/17/2014.

Product
SOTALOL HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106001.
Recalling firm
Aidapak Services, LLC
Quantity
101 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)
Open FDA enforcement record Latest recalls