FDA Drug recall D-0001-2017
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc
- FDA Drug
- Class III
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class III recall of Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc by Biocompatibles U K, citing defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0001-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-07 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Biocompatibles U K |
| Distribution | US |
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
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Identifiers
| ndc | 60635-118-01 |
|---|---|
| ndc | 60635-018-01 |
| ndc | 60635-133-01 |
| ndc | 60635-123-01 |
| code_info | Lot # 476670,476669,476659,475250; Exp 11/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.