Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD70629_16, EXP: 5/29/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W003540, EXP: 6/21/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD52993_16, EXP: 5/20/2014.
CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660
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 Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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