Drug 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;
D-0929-2023
Product summary
- Event
- Event 92690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 209 Bags
- Official record key
drug-enforcement:D-0929-2023
Official wording
Reason: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Code information: Lot # 20230524-0113AB, Exp 22AUG2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Violations