# FDA recall D-0001-2017

> **Biocompatibles U.K., Ltd.** · Class III · drug recall initiated 2016-09-07.

## Product

Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01

## Reason for recall

Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

## Distribution

Distributed nationwide

## Key facts

- **Recall number:** D-0001-2017
- **Recalling firm:** Biocompatibles U.K., Ltd.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-07
- **Report date:** 2016-10-12
- **Termination date:** 2017-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Farnham, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2017

## Citation

> AI Analytics. FDA recall D-0001-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0001-2017. Source: US FDA. Licensed CC0.

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