FDARecalled Jul 26, 2023 · #D-0927-2023
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;
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
- 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;
- Type
- Drugs
- Manufacturer
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Model numbers
- 20230524-6FBB77
- UPCs
- —