← FDA ENFORCEMENT
D-0503-2025Class 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
4875 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 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.

Code / lot info

Lot #: 2504003, Exp. 04/03/2027

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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.