Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
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: 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
Reason Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
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