Recalls / Class II

Class IID-0594-2024

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

Affected lot / code info

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

Why it was recalled

Subpotent Drug: reduced efficacy for epinephrine

Recalling firm

Firm

TAILSTORM HEALTH INC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

158 S Kyrene Rd, N/A, Chandler, Arizona 85226

Distribution

Quantity

12,525 10 mL vials

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-07-03

FDA classified

2024-07-10

Posted by FDA

2024-07-17

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0594-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.