Varithena Kit
FDA Recall NDC 60635-133
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Varithena (NDC 60635-133). A significant event, classified as Class III, was initiated on Sep 07, 2016 by Boston Scientific Corporation. The reported reason for this action was: "Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Sep 07, 2016
Oct 12, 2016
3,254 administration packs
Recall Profile & Regulatory Data
Event ID
75253
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Biocompatibles U.K., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide
Termination Date
Feb 27, 2017
Product Description
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Batch or Lot Expiration Information
Lot# 476670,476669,476659,475250; Exp 11/16
Affected Packages Involved in this Recall
60635-118-01Product
60635-018-01Product
60635-133-01Product
60635-123-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
