Drug product
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
D-1045-2018
Product summary
- Event
- Event 80638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 575 Syringes
- Official record key
drug-enforcement:D-1045-2018
Official wording
Reason: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Code information: Lot 181780003D
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Manufacturing or process control
CGMP deviations