FDA-Drug2023-07-26Class II
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
New England Life Care, Inc. dba Advanced Compounding Solutions
Hazard
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Sold states
Nationwide in the USA
Affected count
209 Bags
Manufactured in
4 Constitution Way Ste L, N/A, Woburn, MA, United States
Products
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0929-2023Don't want to check this manually?
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