Biocompatibles UK, Ltd. recalls Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1…
- Recall date
- August 15, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0113-2025
- FDA classification
- Class III
- Brand / firm
- Biocompatibles UK, Ltd.
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
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).
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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