FDARecalled Jul 9, 2025 · #D-0499-2025
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: Con...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Classification: Class II Distribution: Nationwide in the US
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Tailstorm Health INC
- Model numbers
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- UPCs
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