The Compounding Pharmacy of America recalls Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville,
Recalled September 23, 2015 · FDA recall D-1453-2015 · The Compounding Pharmacy of America
Hazard
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility · FDA Class II
Units
260 mL total volume
Sold at
Nationwide
Description
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product
Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN
Manufacturer(s)
The Compounding Pharmacy of America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →