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

Recall #D-0927-2023 · 07/10/2023

Class II: Risk

Recall Details

Recall Number: D-0927-2023
Classification: Class II
Product Type: Drug
Recalling Firm: New England Life Care, Inc. dba Advanced Compounding Solutions
Status: Terminated
Date Initiated: 07/10/2023
Location: Woburn, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 82 Bags

Reason for Recall

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

Product Description

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;

Distribution Pattern

Nationwide in the USA

Other Recalls by New England Life Care, Inc. dba Advanced Compounding Solutions

Class II: Risk 07/10/2023

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II: Risk 07/10/2023

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II: Risk 07/10/2023

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class III: Low Risk 05/22/2023

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

View all recalls by New England Life Care, Inc. dba Advanced Compounding Solutions →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.