Varithena (polidocanol injectable foam) Administration Pack recall
FDA recall D-0113-2025 · initiated Aug 15, 2024
Biocompatibles UK, Ltd. recalled Varithena (polidocanol injectable foam) Administration Pack in Aug 2024 — an FDA Class III recall (D-0113-2025) because 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).
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
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).
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 432 administration packs
Details
- Product
- 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
- Recalling company
- Biocompatibles UK, Ltd.
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Aug 15, 2024
- FDA report date
- Dec 18, 2024
Frequently asked
- Was Varithena (polidocanol injectable foam) Administration Pack recalled?
- Biocompatibles UK, Ltd. recalled Varithena (polidocanol injectable foam) Administration Pack in Aug 2024 — an FDA Class III recall (D-0113-2025) because 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). Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Varithena (polidocanol injectable foam) Administration Pack recalled?
- Per the FDA enforcement record, the reason for recall D-0113-2025 was: 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).
- Is a recalled Varithena (polidocanol injectable foam) Administration Pack dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Varithena (polidocanol injectable foam) Administration Pack are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0113-2025.