Lidocaine HCL Injection recall
FDA recall D-0594-2024 · initiated Jul 3, 2024
TAILSTORM HEALTH INC recalled Lidocaine HCL Injection in Jul 2024 — an FDA Class II recall (D-0594-2024) because Subpotent Drug: reduced efficacy for epinephrine.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug: reduced efficacy for epinephrine
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 12,525 10 mL vials
Details
- Product
- Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
- Recalling company
- TAILSTORM HEALTH INC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jul 3, 2024
- FDA report date
- Jul 17, 2024
Frequently asked
- Was Lidocaine HCL Injection recalled?
- TAILSTORM HEALTH INC recalled Lidocaine HCL Injection in Jul 2024 — an FDA Class II recall (D-0594-2024) because Subpotent Drug: reduced efficacy for epinephrine. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lidocaine HCL Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0594-2024 was: Subpotent Drug: reduced efficacy for epinephrine
- Is a recalled Lidocaine HCL Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lidocaine HCL Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot Number: 2311003, Expiration Date: 11/13/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0594-2024.