Biocompatibles U.K., Ltd. recalls Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatib…

Recall date

September 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0001-2017

FDA classification

Class III

Brand / firm

Biocompatibles U.K., Ltd.

Sold / distributed

Distributed nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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