FDAClass IIJanuary 22, 2014

Mirtazapine Tablet recall: Labeling Error

MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503

Why was Mirtazapine Tablet recalled?

Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD73525_40, EXP: 5/30/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003005, EXP: 6/11/2014; carBAMazepine ER, Tablet, 100 mg, NDC 00078051005, Pedigree: W003330, 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?

MIRTAZAPINE, Tablet, 7.5 mg has the following codes Pedigree: AD73525_55, EXP: 5/30/2014; Pedigree: W003012, EXP: 6/11/2014; Pedigree: W003334, EXP: 6/18/2014.

Product
MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503
Recalling firm
Aidapak Services, LLC
Quantity
91 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)
Open FDA enforcement record Latest recalls