FDAClass IIJanuary 29, 2014

Raltegravir recall: Labeling Error

RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.

Why was Raltegravir recalled?

Labeling: Label Mixup: RALTEGRAVIR, Tablet, 400 mg may be potentially mis-labeled as one of the following drugs: HYDROCORTISONE, Tablet, 5 mg, NDC00603389919, Pedigree: AD60272_13, EXP: 5/22/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003679, EXP: 6/25/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: AD21790_16, EXP: 5/1/2014.

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?

RALTEGRAVIR, Tablet, 400 mg has the following codes: Pedigree: AD60272_19, EXP: 5/22/2014; Pedigree: W003680, EXP: 6/25/2014; Pedigree: AD21790_22, EXP: 5/1/2014.

Product
RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
Recalling firm
Aidapak Services, LLC
Quantity
183 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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