FDAFDA · Food and drugs·Recall number 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;
Published July 26, 2023 · Recall initiated: July 10, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Distributor
- Nationwide in the USA
- Lot
- Lot # 20230524-6FBB77, Exp 21OCT2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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