# FDA recall D-0113-2025

> **Biocompatibles UK, Ltd.** · Class III · drug recall initiated 2024-08-15.

## 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

- **Recall number:** D-0113-2025
- **Recalling firm:** Biocompatibles UK, Ltd.
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0113-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0113-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*