Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Varithena (polidocanol injectable foam) Administration Pack Recalled by Biocompatibles UK, Ltd. Due to Defective Delivery System: incorrect silicone oil-free NormJect 10...

Date: August 15, 2024
Company: Biocompatibles UK, Ltd.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biocompatibles UK, Ltd. directly.

Affected Products

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

Quantity: 432 administration packs

Why Was This 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).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biocompatibles UK, Ltd.

Biocompatibles UK, Ltd. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report