ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05

Recall Number: D-0928-2023

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.

ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05