FDAClass IIJanuary 29, 2014

Fluvastatin Sodium recall: Labeling Error

FLUVASTATIN SODIUM, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078017615.

Why was Fluvastatin Sodium recalled?

Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD73597_1, EXP: 5/31/2014.

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?

FLUVASTATIN SODIUM, Capsule, 20 mg has the following codes: Pedigree: AD73597_7, EXP: 5/31/2014.

Product
FLUVASTATIN SODIUM, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078017615.
Recalling firm
Aidapak Services, LLC
Quantity
30 Capsules
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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