Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014; LEVOTHYROXINE SODIUM, Tablet, 175
CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760
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.