Compounded preservative-free lidocaine vials lack assurance of sterility
Preservative-free Lidocaine HCl Injection 1%, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 29,700 vials are affected.
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 where sterility of an injectable cannot be assured, a risk of harm with no injuries reported in the source.
Plain-English summary
Lidocaine HCl Injection, USP, 10 mg/mL, 1% (100 mg/10 mL), in 10 mL sterile single dose vials, prescription only, preservative-free, for infiltration and nerve block including caudal and epidural use, marked for office use only, compounded by Medivant Healthcare of Chandler, Arizona, NDC 81483-0000-0, is being recalled. The recalling firm is Tailstorm Health INC. The action covers 29,700 vials.
The stated reason is lack of assurance of sterility: a recent FDA inspection revealed concerns with the sterile manufacturing process. The FDA classified the action as Class II.
Affected lots are 2502004, expiring 2/18/27, and 2503003, expiring 3/19/27. Distribution was nationwide in the US.
Facilities should identify affected stock using the lot numbers above, quarantine it, and follow the instructions issued by the firm.
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
- Category
- Drug — Compounded injectable
- Affected units
- 29,700
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.
Part of a larger recall action
This product is one of 6 recalled by Tailstorm Health INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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