FDARecalled Jul 9, 2025 · #D-0502-2025
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...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Classification: Class II Distribution: Nationwide in the US
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Tailstorm Health INC
- Model numbers
- —
- UPCs
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