Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Product description
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
Lot numbers, UPCs & expiration codes
Lot #: 2504003, Exp. 04/03/2027
Where it was sold
Nationwide in the US
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-0503-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 2, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 4875 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tailstorm Health INC
Original FDA data
Every field from FDA enforcement report D-0503-2025, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96996
- Address
- 24416 N 19th Ave Ste 200
- Code information
- Lot #: 2504003, Exp. 04/03/2027
- Postal code
- 85085-1400
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0503-2025
- Classification
- Class II
- Recalling firm
- Tailstorm Health INC
- Product quantity
- 4875 vials
- Reason for recall
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 2, 2025
- Center classification date
- Jun 30, 2025