FDAFDA · Food and drugs·Recall number D-0498-2025
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.
Published July 9, 2025 · Recall initiated: June 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Tailstorm Health INC
- Distributor
- Nationwide in the US
- Lot
- Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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