FDAHealthJune 2, 2025
Tailstorm Health INC — BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesi
⚠️ 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
- BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
- Brand
- Tailstorm Health INC
- Lot code
- 2502005
Additional details
Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 975 vials.
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