FDA recall D-0113-2025

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).

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2024-08-15

Report date

2024-12-18

Termination date

2025-02-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Farnham, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0113-2025