FDAClass IIJanuary 29, 2014

Albuterol Sulfate ER recall: Labeling Error

ALBUTEROL SULFATE ER, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378412201.

Why was Albuterol Sulfate ER recalled?

Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014.

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?

ALBUTEROL SULFATE ER, Tablet, 4 mg has the following codes: Pedigree: W003578, EXP: 6/24/2014.

Product
ALBUTEROL SULFATE ER, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378412201.
Recalling firm
Aidapak Services, LLC
Quantity
100 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