FDAClass IIJanuary 22, 2014

hydrALAZINE HCl Tablet recall: Labeling Error

hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401

Why was hydrALAZINE HCl Tablet recalled?

Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014.

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?

hydrALAZINE HCl Tablet, 100 mg has the following codes Pedigree: AD46312_13, EXP: 5/16/2014; Pedigree: AD73652_4, EXP: 5/29/2014; Pedigree: AD30197_7, EXP: 5/9/2014.

Product
hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401
Recalling firm
Aidapak Services, LLC
Quantity
400 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