FDA recall D-540-2014

Aidapak Services, LLC · Class II · drug

Product

CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173

Reason for recall

Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, ND

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-540-2014