Recalls / Class II

Class IID-550-2014

Product

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

Affected lot / code info

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.

Why it was 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,

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

1,582 Lozenges

Distribution pattern

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

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-16

Posted by FDA

2014-01-22

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-550-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.