Drug product
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
D-0928-2023
Product summary
- Event
- Event 92690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Syringes
- Official record key
drug-enforcement:D-0928-2023
Official wording
Reason: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Code information: Lot # 20230524-530F73, Exp 21OCT2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Violations