FDAFDA · Food and drugs·Recall number D-0113-2025
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
Published December 18, 2024 · Recall initiated: August 15, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biocompatibles UK, Ltd.
- Distributor
- Nationwide in the USA.
- Lot
- Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United Kingdom
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