Status
Ongoing
Drug Enforcement D-0503-2025
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Classification
Class II
Report Date
July 9, 2025
Termination Date
—
Product Information
- 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.
- Product quantity
- 4875 vials
- Reason for recall
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Tailstorm Health INC
- Address
-
24416 N 19th Ave Ste 200
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0503-2025
- Event ID
- 96996
- Recall initiation date
- June 2, 2025
- Center classification date
- June 30, 2025
- Code info
- Lot #: 2504003, Exp. 04/03/2027
- More code info
- —