Drug product
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.
D-0502-2025
Product summary
- Event
- Event 96996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2825 vials
- Official record key
drug-enforcement:D-0502-2025
Official wording
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Code information: Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility