FDAClass IIJanuary 29, 2014

Terbutaline Sulfate recall: Labeling Error

TERBUTALINE SULFATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115261101.

Why was Terbutaline Sulfate recalled?

Labeling: Label Mixup: TERBUTALINE SULFATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD52778_85, EXP: 5/21/2014.

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?

TERBUTALINE SULFATE, Tablet, 2.5 mg has the following codes: Pedigree: AD52778_88, EXP: 5/21/2014.

Product
TERBUTALINE SULFATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115261101.
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)
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