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;
Reported: July 26, 2023 Initiated: July 10, 2023 #D-0927-2023
Product Description
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;
Reason for Recall
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Details
- Units Affected
- 82 Bags
- Distribution
- Nationwide in the USA
- Location
- Woburn, MA
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by New England Life Care, Inc. dba Advanced Compounding Solutions. Units affected: 82 Bags.
Why was this product recalled? ▼
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 26, 2023. Severity: Moderate. Recall number: D-0927-2023.
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