Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Recall Number: D-1450-2015

Firm: The Compounding Pharmacy of America

Classification: Class II

Status: Terminated

Report Date: 20150923

Initiation Date: 20150602

Termination Date: 20160210

Reason for Recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Product Description

Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN