FDAFDA · Food and drugs·Recall number D-862-2014
NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.
Published January 29, 2014 · Recall initiated: July 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Aidapak Services, LLC
- Distributor
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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