Recalls / Class II
Class IID-0498-2025
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.
- Affected lot / code info
- Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27
Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recalling firm
- Firm
- Tailstorm Health INC
- Type
- Voluntary: Firm initiated
- Address
- 24416 N 19th Ave Ste 200, Phoenix, Arizona 85085-1400
Distribution
- Quantity
- 29,700 vials
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-06-02
- FDA classified
- 2025-06-30
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0498-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.