FDA recall D-862-2014

Aidapak Services, LLC · Class II · drug

Product

NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.

Reason for recall

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

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-862-2014