D-550-2014 Class II Terminated
FDA drug recall D-550-2014 was initiated by Aidapak Services, LLC on July 2, 2013 and is designated Class II. Reason for recall: 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, Ta… The recall status is terminated (terminated February 7, 2014). Affected quantity: 1,582 Lozenges.
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2014
- Initiation Date
- July 2, 2013
- Termination Date
- February 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,582 Lozenges
Product Description
NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769
Reason for Recall
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,
Distribution Pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code Information
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.