Nicotine Polacrilex recall: Labeling Error
NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.
Why was Nicotine Polacrilex recalled?
Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as one of the following drugs: ESTRADIOL, Tablet, 0.5 mg, NDC 00555089902, Pedigree: AD30993_11, EXP: 5/9/2014; ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: W002973, EXP: 6/11/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: W003730, EXP: 6/26/2014; ESZOPICLONE, T
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: AD32973_7, EXP: 5/9/2014; Pedigree: W002974, EXP: 6/11/2014; Pedigree: W003749, EXP: 6/26/2014; Pedigree: W002766, EXP: 6/6/2014; Pedigree: AD21858_1, EXP: 5/1/2014; Pedigree: AD46333_10, EXP: 5/16/2014.
- Product
- NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 1216 Lozenges
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)