FDAClass IIJanuary 22, 2014

Nicotine Polacrilex Lozenge recall: Labeling Error

NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769

Why was Nicotine Polacrilex Lozenge recalled?

Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: AD52433_1, EXP: 5/17/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70700_1, EXP: 5/29/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD73623_1, EXP: 5/30/2014; FOLIC ACID, Tablet, 1 mg, NDC 65162036110,

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?

NICOTINE POLACRILEX Lozenge, 2 mg has the following codes Pedigree: AD52433_4, EXP: 5/17/2014; Pedigree: AD70700_4, EXP: 5/29/2014; Pedigree: AD73623_7, EXP: 5/30/2014; Pedigree: W003823, EXP: 6/27/2014; Pedigree: W003463, EXP: 6/20/2014.

Product
NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769
Recalling firm
Aidapak Services, LLC
Quantity
1,582 Lozenges
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