PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;

Recall Number: D-0927-2023

Firm: New England Life Care, Inc. dba Advanced Compounding Solutions

Classification: Class II

Status: Terminated

Report Date: 20230726

Initiation Date: 20230710

Termination Date: 20231204

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;