Vitamin D Recall
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Questions & Answers
Side Effects & Adverse Reactions
Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted.
Keep out of the reach of children.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
History
There is currently no drug history available for this drug.
Other Information
Ergocalciferol capsules, USP, is a synthetic calcium regulator for oral administration.
Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity.
There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity.
One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU.
Each capsule contains 1.25 mg (50,000 USP Units vitamin D) of ergocalciferol, USP, in an edible vegetable oil.
Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10 (19),22-tetraen-3-ol,(3β,5Z,7E,22E)-;(C28H44O) with a molecular weight of 396.65, and has the following structural formula:
The soft gelatin capsule and imprinting ink contain: ammonium hydroxide, butyl alcohol, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, isopropyl alcohol, propylene glycol, purified water, shellac glaze, simethicone, soybean oil, and titanium dioxide.
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