Reported Dec 18, 2024 · Terminated

Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1…

Biocompatibles UK, Ltd.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biocompatibles UK, Ltd. · Chapman House · Farnham · N/A

Is this the product you have?

  • 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 codes and dates
    • Lot # 34067418
    • Exp. March 2026
    • 34067419
    • Exp. March 2026
Amount recalled
432 administration packs

Where it was sold

  • Nationwide

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).

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 21, 2025 · Data as of Sep 19, 8:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.