Drug product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
D-0968-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 604080 syringes
- Official record key
drug-enforcement:D-0968-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: RC1050A, Exp. 5/30/2022; RC1051B, Exp. 6/6/2022; RC1053A, Exp. 6/27/2022; RC2001A, Exp. 7/19/2022; RC2002A, Exp. 8/13/2022; RC2003A, Exp. 8/28/2022; RC2004A, Exp. 9/8/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility