Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, ...
FDA Recall #D-0113-2025 — Class III — August 15, 2024
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
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).
Recalling Firm
Biocompatibles UK, Ltd. — Farnham
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
432 administration packs
Distribution
Nationwide in the USA.
Code Information
Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated