Tailstorm Health INC recalls LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Ner
Recalled July 9, 2025 · FDA recall D-0498-2025 · Tailstorm Health
Hazard
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. · FDA Class II
Units
29,700 vials
Sold at
Nationwide in the US
Description
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Product
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.
Manufacturer(s)
Tailstorm Health INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →