TAILSTORM HEALTH INC: Drug Recall

Recall #D-0594-2024 · 07/03/2024

Class II: Risk

Recall Details

Recall Number: D-0594-2024
Classification: Class II
Product Type: Drug
Recalling Firm: TAILSTORM HEALTH INC
Status: Ongoing
Date Initiated: 07/03/2024
Location: Chandler, AZ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,525 10 mL vials

Reason for Recall

Subpotent Drug: reduced efficacy for epinephrine

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

Distribution Pattern

Nationwide in the USA

Other Recalls by TAILSTORM HEALTH INC

Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

View all recalls by TAILSTORM HEALTH INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.