FDA recall D-568-2014

Aidapak Services, LLC · Class II · drug

Product

FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578

Reason for recall

Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
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-568-2014