BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
Reported: July 9, 2025 Initiated: June 2, 2025 #D-0499-2025
Product Description
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
Reason for Recall
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Details
- Recalling Firm
- Tailstorm Health INC
- Units Affected
- 975 vials
- Distribution
- Nationwide in the US
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.. Recalled by Tailstorm Health INC. Units affected: 975 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 9, 2025. Severity: Moderate. Recall number: D-0499-2025.
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