Varithena — Class III drug recall D-0113-2025
Terminated recall by Biocompatibles UK, Ltd., reported 2024-12-18, distributed nationwide. Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the
| Recall number | D-0113-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocompatibles UK, Ltd., Farnham, United Kingdom |
| Recall initiated | 2024-08-15 |
| Classified | 2024-12-06 |
| Reported by FDA | 2024-12-18 |
| Terminated | 2025-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 432 administration |
| Lot numbers | 34067418, 34067419 |
| Expiration dates | 2026-03-20 |
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
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0113-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.