BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vi
Summary
The FDA issued a Class II for BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5% by Tailstorm Health INC. Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process..
Details
Source
Drug Recall
External ID
D-0499-2025
Action Date
2025-07-09
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
Quantity Affected: 975 vials
Reason for Recall
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-02
Company
Phoenix, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Tailstorm Health INC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tailstorm Health INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tailstorm Health INC have FDA actions?
Tailstorm Health INC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0499-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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