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Drug FDA Class II Ongoing Sub/super-potent

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

TAILSTORM HEALTH INC Published Jul 17, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact TAILSTORM HEALTH INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Subpotent Drug: reduced efficacy for epinephrine

Hazards

Subpotent Epinephrine · primary

Affected products (1)

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

12,525 10 mL vials

Lot codes: Number
Code info: Lot Number: 2311003, Expiration Date: 11/13/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 3, 2024
  2. Published
    Jul 17, 2024
Recall number
D-0594-2024
Agency
U.S. Food and Drug Administration
Country
US

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.