22 FDA recalls mention Cholecalciferol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cholecalciferol.
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
Reason Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS…
Reason Labeling: Label Mixup: CHOLECALCIFEROL, Capsule, 2000 units may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE HYCLATE…
Reason Labeling: Label Mixup: CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg may have potentially been mislabeled as one of the following…
Reason Labeling: Label Mixup: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units may be potentially mis-labeled as the following drug…
Reason Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL…
Reason Labeling: Label Mixup; CHOLECALCIFEROL Capsule, 50000 units may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077…
Reason Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060…
Reason Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC…
Reason Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736…
Reason Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
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