FDAHealthJune 2, 2025
Tailstorm Health INC — 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-D
⚠️ Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 2, 2025
Nationwide in the US
What's affected?
- 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.
- Brand
- Tailstorm Health INC
- Lot code
- 2503004
Additional details
Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2825 vials.
Get Health recall alerts
Delivered to your inbox. Free. No account required.