FDAFDA · Food and drugs·Recall number D-0001-2017
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Published October 12, 2016 · Recall initiated: September 7, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VARITHENA
- Manufacturer
- Biocompatibles U.K., Ltd.
- Distributor
- Distributed nationwide
- Lot
- Lot # 476670,476669,476659,475250; Exp 11/16
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United Kingdom
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