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

Recall #D-0778-2023 · 05/22/2023

Class III: Low Risk

Recall Details

Recall Number: D-0778-2023
Classification: Class III
Product Type: Drug
Recalling Firm: New England Life Care, Inc. dba Advanced Compounding Solutions
Status: Terminated
Date Initiated: 05/22/2023
Location: Woburn, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 198

Reason for Recall

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

Product Description

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25

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 II: Risk 07/10/2023

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

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.