FDA recall D-605-2014

Aidapak Services, LLC · Class II · drug

Product

MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991001406

Reason for recall

Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD25452_13, EXP: 5/3/2014; PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD28322_4, EXP: 4/30/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD70655_11, EXP: 5/28/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree

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-605-2014