Varithena — Class III drug recall D-0001-2017
Terminated recall by Biocompatibles U.K., Ltd., reported 2016-10-12, distributed nationwide. Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
| Recall number | D-0001-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocompatibles U.K., Ltd., Farnham, N/A, United Kingdom |
| Recall initiated | 2016-09-07 |
| Classified | 2016-10-03 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 3,254 administration |
| NDC | 60635-0018-01, 60635-0118, 60635-0118-01, 60635-0123, 60635-0123-01, 60635-0133, 60635-0133-01 |
| Lot numbers | 11/16, 475250, 476659, 476669, 476670 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0001-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.