Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 V
Summary
The FDA issued a Class III for Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicon by Biocompatibles UK, Ltd.. Reason: Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone o.
Details
Source
Drug Recall
External ID
D-0113-2025
Action Date
2024-12-18
Status
Terminated
Category
drug
Product Description
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
Lot/Code Info: Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
Quantity Affected: 432 administration packs
Reason for Recall
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-15
Company
Farnham
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 105 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Biocompatibles UK, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biocompatibles UK, Ltd. have FDA actions?
This is the only FDA action we have on record for Biocompatibles UK, Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0113-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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