D-0113-2025 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2024
- Initiation Date
- August 15, 2024
- Termination Date
- February 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 432 administration packs
Product Description
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).
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026