Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Recall Number: D-0348-2016

Firm: Downing Labs, LLC

Classification: Class II

Status: Terminated

Report Date: 20151125

Initiation Date: 20151016

Termination Date: 20160922

Lack of Assurance of Sterility

Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435