FDAHealthJune 2, 2025
Tailstorm Health INC — 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
⚠️ 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 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.
- Brand
- Tailstorm Health INC
- Lot code
- 2504003
Additional details
Lot #: 2504003, Exp. 04/03/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4875 vials.
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