Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Recall Number: D-1576-2015

Firm: The Compounding Pharmacy of America

Classification: Class II

Status: Terminated

Report Date: 20150923

Initiation Date: 20150602

Termination Date: 20160210

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

Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN