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

FDA recall notice · announced October 12, 2016 · Biocompatibles U.k

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Distributed nationwide
Lot/code information: Lot # 476670,476669,476659,475250; Exp 11/16
Quantity: 3,254 administration packs
Status: Terminated
Products in this recall event:
- Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01 (D-0001-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.