REMfresh Advanced Ion-Powered Melatonin
Reason cGMP deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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
MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991001406
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
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