Lidocaine HCl Injection recalled for sterility assurance concerns
Tailstorm Health is recalling Lidocaine HCl Injection vials nationwide due to concerns with the sterile manufacturing process identified during FDA inspection.
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: FDA Class II recall for sterility concerns in an injectable pharmaceutical. No illnesses or injuries have been reported, but loss of assurance of sterility in an injection poses significant risk of serious infection and other harm.
Plain-English summary
Tailstorm Health INC is recalling 29,700 vials of Lidocaine HCl Injection, USP, 10mg/mL, 1% nationally. The affected lots are 2502004 (expiration 2/18/27) and 2503003 (expiration 3/19/27). The product is manufactured by Tailstorm Health INC and compounded by Medivant Healthcare in Chandler, Arizona.
The FDA identified concerns with the sterile manufacturing process during a recent inspection. This injectable product is intended for infiltration and nerve block use, including caudal and epidural use, in office settings.
Healthcare providers and pharmacies that have received affected lot numbers should immediately cease use of these vials and contact Tailstorm Health INC. The product was distributed nationwide.
The recalled product
- 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, 8522
- Manufacturer
- Tailstorm Health INC
- Hazard
- sterility-concern
- 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 (4)
- Lot #s: 2502004
- Exp. 2/18/27
- 2503003
- Exp. 3/19/27
Distribution
Distributed nationwide across the United States.
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