Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single ...

FDA Recall #D-0594-2024 — Class II — July 3, 2024

Recall #D-0594-2024 Date: July 3, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Subpotent Drug: reduced efficacy for epinephrine

Recalling Firm

TAILSTORM HEALTH INC — Chandler, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

12,525 10 mL vials

Distribution

Nationwide in the USA

Code Information

Lot Number: 2311003, Expiration Date: 11/13/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated