FDA Drug recall D-0113-2025
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer U…
- FDA Drug
- Class III
- terminated
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class III recall of Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer U… by Biocompatibles Uk, citing 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 S….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0113-2025 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-08-15 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Biocompatibles Uk |
| Distribution | US |
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
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).
Identifiers
| code_info | Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0113-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.