D-965-2014 Class II Terminated

Recalled by Aidapak Services, LLC — Vancouver, WA

Recall Details

Product Type
Drugs
Report Date
January 29, 2014
Initiation Date
July 2, 2013
Termination Date
February 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500 Tablets

Product Description

guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.

Reason for Recall

Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2

Distribution Pattern

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

Code Information

guanFACINE HCl, Tablet, 1 mg has the following codes: Pedigree: W002728, EXP: 4/30/2014; Pedigree: AD39611_1, EXP: 4/30/2014; Pedigree: W003791, EXP: 6/27/2014; Pedigree: AD73525_13, EXP: 4/30/2014.