Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot Number: 2311003, Expiration Date: 11/13/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0594-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 3, 2024
- FDA report date
- Jul 17, 2024
- Quantity
- 12,525 10 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TAILSTORM HEALTH INC
Original FDA data
Every field from FDA enforcement report D-0594-2024, exactly as published.
Show all FDA fields
- City
- Chandler
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94930
- Address
- 158 S Kyrene Rd
- Code information
- Lot Number: 2311003, Expiration Date: 11/13/2024
- Postal code
- 85226
- Report date
- Jul 17, 2024
- Product type
- Drugs
- Recall number
- D-0594-2024
- Classification
- Class II
- Recalling firm
- TAILSTORM HEALTH INC
- Product quantity
- 12,525 10 mL vials
- Reason for recall
- Subpotent Drug: reduced efficacy for epinephrine
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Jul 3, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 10, 2024