Class IIITerminated

Varithena (polidocanol injectable foam) Administration Pack recall

FDA recall D-0113-2025 · initiated Aug 15, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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).

Details

Product: 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
Recalling company: Biocompatibles UK, Ltd.
Classification: Class III
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA.
Initiated: Aug 15, 2024
FDA report date: Dec 18, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0113-2025 ↗

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