FDAClass IIJanuary 22, 2014

Melatonin recall: Labeling Error

MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466

Why was Melatonin recalled?

Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as QUETIAPINE FUMARATE, Tablet, 12.5 MG (1/2 of 25 MG), NDC 47335090288, Pedigree: AD21790_79, EXP: 5/1/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD73521_13, EXP: 5/30/2014.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

MELATONIN, Tablet, 1 mg has the following codes Pedigree: AD21846_17, EXP: 5/1/2014; Pedigree: AD73521_19, EXP: 5/30/2014.

Product
MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466
Recalling firm
Aidapak Services, LLC
Quantity
359 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls