Drug product
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
D-0004-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,992 5 mL syringes
- Official record key
drug-enforcement:D-0004-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275788, Exp. 10/10/2023; 17-275872, Exp. 10/11/2023; 17-275922, Exp. 10/12/2023; 17-275972, 17-275973, Exp. 10/15/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility