Drug product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
D-0099-2023
Product summary
- Event
- Event 91450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38,830 syringes
- Official record key
drug-enforcement:D-0099-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: RC2011A, Exp. 2/22/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility