PHENYLephrine HCl 10mg added to 0 recalled over manufacturing violations

Recall date

July 10, 2023

Source

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

Official notice title

New England Life Care, Inc. dba Advanced Compounding Solutions recalls PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compound…

Recall number

D-0927-2023

FDA classification

Class II

Brand / firm

New England Life Care, Inc. dba Advanced Compounding Solutions

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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;