Recalls / Class II

Class IID-605-2014

Product

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

Affected lot / code info

MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD25452_16, EXP: 5/3/2014; Pedigree: AD28322_7, EXP: 5/6/2014; Pedigree: AD70655_14, EXP: 5/28/2014; Pedigree: W003999, EXP: 7/1/2014; Pedigree: AD32325_7, EXP: 5/9/2014; Pedigree: AD68019_7, EXP: 5/28/2014.

Why it was recalled

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

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

718 Tablets

Distribution pattern

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

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-16

Posted by FDA

2014-01-22

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-605-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.