FDA recall D-0001-2017

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

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

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