FDAClass IIJanuary 22, 2014

Simvastatin Tablet recall: Labeling Error

SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714068303

Why was Simvastatin Tablet recalled?

Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003591, 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?

SIMVASTATIN, Tablet, 20 mg has the following code Pedigree: W003580, EXP: 6/24/2014.

Product
SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714068303
Recalling firm
Aidapak Services, LLC
Quantity
1,000 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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