Reported Oct 12, 2016 · Terminated

Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by…

Biocompatibles U.K., Ltd.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biocompatibles U.K., Ltd. · Bortoli House · Farnham, N/A · N/A

Is this the product you have?

  • Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Lot codes and dates
    • Lot # 476670
    • 476669
    • 476659
    • 475250
    • Exp 11/16
Amount recalled
3,254 administration packs

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 27, 2017 · Data as of Sep 19, 7:18 PM UTC

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