D-0502-2025 Class II Ongoing
FDA drug recall D-0502-2025 was initiated by Tailstorm Health INC on June 2, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. The recall status is ongoing. Affected quantity: 2825 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2025
- Initiation Date
- June 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2825 vials
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Distribution Pattern
Nationwide in the US
Code Information
Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026