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