FDAClass IIJanuary 29, 2014

guanFACINE HC recall: Labeling Error

guanFACINE HC, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378116001.

Why was guanFACINE HC recalled?

Labeling: Label Mixup: guanFACINE HC, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD46265_22, EXP: 5/15/2014; FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 60505251002, Pedigree: AD46414_19, EXP: 5/16/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70629_4, EXP: 5/29/2014; guanFACINE HCl,

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?

guanFACINE HC, Tablet, 1 mg has the following codes: Pedigree: AD46265_25, EXP: 5/15/2014; Pedigree: AD46414_22, EXP: 5/16/2014; Pedigree: AD70629_7, EXP: 5/29/2014; Pedigree: W003007, EXP: 6/12/2014.

Product
guanFACINE HC, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378116001.
Recalling firm
Aidapak Services, LLC
Quantity
500 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)
Open FDA enforcement record Latest recalls