FDA-Drug2016-10-12Class III

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

Biocompatibles U.K., Ltd.
Hazard

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

Sold states
Distributed nationwide
Affected count
3,254 administration packs
Manufactured in
Bortoli House, Weydon Lane; Old Farnham Lane, Farnham, N/A, United Kingdom
Products
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01

Official notice

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

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