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 For Use With Varithena Recalled by Biocompatibles U.K., Ltd. Due to Defective Delivery System: Incorrect type of syringe found...

Date: September 7, 2016
Company: Biocompatibles U.K., 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 U.K., Ltd. directly.

Affected Products

Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01

Quantity: 3,254 administration packs

Why Was This Recalled?

Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biocompatibles U.K., Ltd.

Biocompatibles U.K., Ltd. has 2 total recalls tracked by RecallDetector.

Related Recalls

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