Drug 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;
D-0927-2023
Product summary
- Event
- Event 92690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82 Bags
- Official record key
drug-enforcement:D-0927-2023
Official wording
Reason: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Code information: Lot # 20230524-6FBB77, Exp 21OCT2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Violations