FDAClass IIJanuary 29, 2014

Sirolimus recall: Labeling Error

SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.

Why was Sirolimus recalled?

Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_34, EXP: 5/22/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003325, EXP: 6/18/2014.

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?

SIROLIMUS, Tablet, 1 mg has the following product codes: Pedigree: AD60272_43, EXP: 5/22/2014; Pedigree: W003329, EXP: 6/18/2014.

Product
SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.
Recalling firm
Aidapak Services, LLC
Quantity
200 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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