FDAClass IIJanuary 22, 2014

DARUNAVIR Tablet recall: Labeling Error

DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630

Why was DARUNAVIR Tablet recalled?

Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg, NDC 52544016201, Pedigree: W004005, EXP: 7/1/2014.

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?

DARUNAVIR, Tablet, 800 mg has the following code Pedigree: W003929, EXP: 7/1/2014.

Product
DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630
Recalling firm
Aidapak Services, LLC
Quantity
90 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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