← FDA ENFORCEMENT
D-0501-2025Class 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
14,725 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

KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.

Code / lot info

Lot: 2502009, Exp. 3/2/2026

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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.