FDA recall D-497-2014

Aidapak Services, LLC · Class II · drug

Product

MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813

Reason for recall

Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400

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-497-2014