FDAFDA · Food and drugs·Recall number D-0503-2025
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.
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 #: 2504003, Exp. 04/03/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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