FDAHealthJune 2, 2025
Tailstorm Health INC — 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-F
⚠️ Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 2, 2025
Nationwide in the US
What's affected?
- 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.
- Brand
- Tailstorm Health INC
- Lot code
- 2502004
Additional details
Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 29,700 vials.
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