Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053
CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360
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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.