CLASS III Drug recall · Reported 18 Dec 2024 · FDA Enforcement Report
Varithena (polidocanol injectable foam) Administration Pack recalled
Biocompatibles UK is recalling Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free, distributed nationwide in the US. The recall was initiated on 15 Aug 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0113-2025
- FDA event ID
- 95820
- Recalling firm
- Biocompatibles UK, Farnham
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Aug 2024
- FDA classified
- 6 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Aug 2024 | Recall initiated by company | |
| 6 Dec 2024 | Classified by FDA | +113 days |
| 18 Dec 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it 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).
Which lots are affected?
Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.