Drug product
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
D-0499-2025
Product summary
- Event
- Event 96996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 975 vials
- Official record key
drug-enforcement:D-0499-2025
Official wording
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Code information: Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility