FDAClass IIIOctober 12, 2016

Varithena recall

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

Why was Varithena recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 476670,476669,476659,475250; Exp 11/16

Product
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Recalling firm
Biocompatibles U.K., Ltd.
Quantity
3,254 administration packs
Distribution
Distributed nationwide
Recall date
October 12, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls