Drug product
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
D-0503-2025
Product summary
- Event
- Event 96996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4875 vials
- Official record key
drug-enforcement:D-0503-2025
Official wording
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Code information: Lot #: 2504003, Exp. 04/03/2027
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility