FDAClass IIJanuary 29, 2014

Tacrolimus recall: Labeling Error

TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.

Why was Tacrolimus recalled?

Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014; ATOMOXE

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?

TACROLIMUS, Capsule, 1 mg has the following codes: Pedigree: AD37056_1, EXP: 5/10/2014; Pedigree: AD56917_7, EXP: 5/21/2014; Pedigree: AD73627_14, EXP: 5/30/2014; Pedigree: W003704, EXP: 6/26/2014; Pedigree: W002508, EXP: 6/3/2014; Pedigree: W003049, EXP: 6/12/2014; Pedigree: W003352, EXP: 3/31/2014.

Product
TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.
Recalling firm
Aidapak Services, LLC
Quantity
700 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)
Open FDA enforcement record Latest recalls