← FDA ENFORCEMENT
D-0498-2025Class II

Tailstorm Health INC

Recalling firm
Tailstorm Health INC
Product type
Drug
Status
Ongoing
Report date
2025-07-09
Distribution
Nationwide in the US
Firm state
AZ
Product quantity
29,700 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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.

Code / lot info

Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.