Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014; HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014; MELATONIN, Tablet, 3 mg, NDC
VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001
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 Presence of a Foreign Substance; black particles observed in liquid
Reason Lack of assurance of sterility.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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