FDAClass IIJanuary 29, 2014

Fluvastatin recall: Labeling Error

FLUVASTATIN, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378802077.

Why was Fluvastatin recalled?

Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the following drug: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, NDC 00603254421, Pedigree: W002654, EXP: 6/4/2014.

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, Capsule, 20 mg has the following codes: Pedigree: 00378802077, EXP: W002655.

Product
FLUVASTATIN, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378802077.
Recalling firm
Aidapak Services, LLC
Quantity
90 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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