Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Recall Number: D-0342-2016

Firm: Downing Labs, LLC

Classification: Class II

Status: Terminated

Report Date: 20151125

Initiation Date: 20151016

Termination Date: 20160922

Lack of Assurance of Sterility

Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435