FDA Recall D-0594-2024
TAILSTORM HEALTH INC · Chandler, AZ
Class II Ongoing 680 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Subpotent Drug: reduced efficacy for epinephrine
Recall record
- Recall number
D-0594-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-07-03
- Classified by FDA Center
- 2024-07-10
- FDA published
- 2024-07-17
- Recalling firm
- TAILSTORM HEALTH INC
- Firm location
- Chandler, AZ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.