Drug product
vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
D-1048-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,640 Syringes
- Official record key
drug-enforcement:D-1048-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-273867, Exp.9/10/2023; 17-272606, Exp.8/20/2023; 17-272225, 8/13/2023; 17-272036, Exp. 8/9/2023; 17-271503, Exp. 7/31/2023; 17-271427, Exp. 7/30/2023; 17-271264, Exp. 7/26/2023; 17-270970, Exp.7/23/2023; 17-270784, Exp. 7/19/2023; 17-270674, Exp. 7/18/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility