Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
Recall Number: D-0929-2023
Firm: New England Life Care, Inc. dba Advanced Compounding Solutions
Classification: Class II
Status: Terminated
Report Date: 20230726
Initiation Date: 20230710
Termination Date: 20231204
Reason for Recall
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Product Description
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;