FDARecalled Jul 26, 2023 · #D-0929-2023
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;
Hazard
Class II — temporary health risk
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CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. Classification: Class II Distribution: Nationwide in the USA
Product details
- Product
- 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;
- Type
- Drugs
- Manufacturer
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Model numbers
- 20230524-0113AB
- UPCs
- —