Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Com
Summary
The FDA issued a Class II for Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,0 by TAILSTORM HEALTH INC. Reason: Subpotent Drug: reduced efficacy for epinephrine.
Details
Source
Drug Recall
External ID
D-0594-2024
Action Date
2024-07-17
Status
Ongoing
Category
drug
Product Description
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
Lot/Code Info: Lot Number: 2311003, Expiration Date: 11/13/2024
Quantity Affected: 12,525 10 mL vials
Reason for Recall
Subpotent Drug: reduced efficacy for epinephrine
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-03
Company
Chandler, 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 61 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-0594-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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