Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL Recalled by New England Life Care, Inc. dba Advanced Compounding Solutions Due to CGMP Violations- that spaces adjacent to the production...

Date: July 10, 2023
Company: New England Life Care, Inc. dba Advanced Compounding Solutions
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact New England Life Care, Inc. dba Advanced Compounding Solutions directly.

Affected Products

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;

Quantity: 82 Bags

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About New England Life Care, Inc. dba Advanced Compounding Solutions

New England Life Care, Inc. dba Advanced Compounding Solutions has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report