Reported Jul 26, 2023 · Terminated

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced…

New England Life Care, Inc. dba Advanced Compounding Solutions

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: New England Life Care, Inc. dba Advanced Compounding Solutions · 4 Constitution Way Ste L · Woburn, MA · 01801-1042

Is this the product you have?

  • 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
  • NDC71546-450-25
Lot codes and dates
    • Lot # 20230524-6FBB77
    • Exp 21OCT2023
Amount recalled
82 Bags

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 4, 2023 · Data as of Sep 19, 6:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.