FDAClass IIJanuary 29, 2014

Sennosides recall: Labeling Error

SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182109301.

Why was Sennosides recalled?

Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of the following drugs: FEXOFENADINE HCL, Tablet, 180 mg, NDC 41167412003, Pedigree: AD62834_1, EXP: 5/23/2014; TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: W002976, EXP: 6/11/2014; LORATADINE, Tablet, 10 mg, NDC 45802065078, Pedigree: W003253, EXP: 6/17/2014.

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?

SENNOSIDES, Tablet, 8.6 mg has the following codes: Pedigree: AD62992_14, EXP: 5/23/2014; Pedigree: W002979, EXP: 6/11/2014; Pedigree: W003256, EXP: 6/17/2014.

Product
SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182109301.
Recalling firm
Aidapak Services, LLC
Quantity
1400 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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