Data Composite

Recall D-0503-2025

US Class II Ongoing · initiated 2025-06-02

Recalling firm

Tailstorm Health INC, AZ

Product

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.

Reason for recall

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

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