New England Life Care, Inc. dba Advanced Compounding Solutions recalls Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions…

Recall date

May 22, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0778-2023

FDA classification

Class III

Brand / firm

New England Life Care, Inc. dba Advanced Compounding Solutions

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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