Lidocaine HCL Sterile Injection Recalled Due to Sterility Assurance Concerns
Tailstorm Health is recalling LIDOcaine HCL Sterile Injection (20 mg/mL, 10mL vials) nationwide due to lack of assurance of sterility identified during FDA inspection. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a sterile injection product with lack of assurance of sterility, creating a risk of harm through potential contamination. No illnesses or injuries have been reported, so per the rubric, the score does not exceed 3.
Plain-English summary
Tailstorm Health INC is recalling LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 10mL sterile single-dose vials due to lack of assurance of sterility. The recall affects 4,875 vials of lot #2504003 (expiration date April 3, 2027) that were distributed nationwide.
An FDA inspection revealed concerns with the sterile manufacturing process that prevent the company from assuring the sterility of the affected product. Because this is a sterile injection product, any lack of sterility assurance creates a potential risk for infection or other complications if the product is administered.
No illnesses or injuries related to this product have been reported to date.
The recalled product
- 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.
- Manufacturer
- Tailstorm Health INC
- Category
- Drug — Injectable Anesthetic
- Hazard
- sterility-assurance
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 2504003
- Exp. 04/03/2027
Distribution
Distributed nationwide across the United States.
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