Drug 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
D-0113-2025
Product summary
- Event
- Event 95820
- Status
- Terminated
- Classification
- Class III
- Quantity
- 432 administration packs
- Official record key
drug-enforcement:D-0113-2025
Official wording
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).
Code information: Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
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).