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 Compoundi
Recalled July 26, 2023 · FDA recall D-0927-2023 · New England Life Care, Inc.
Hazard
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. · FDA Class II
Units
82 Bags
Sold at
Nationwide in the USA
Description
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Product
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;
Manufacturer(s)
New England Life Care, Inc. dba Advanced Compounding Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →