September 2016 FDA Recall Varithena by Biocompatibles U.k., Ltd.
D-0001-2017 - Defective Delivery System

This Class III drug recall was voluntarily initiated by Biocompatibles U.k., Ltd. on September 7, 2016 for the product Varithena. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0001-2017

Reason for Recall
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Initiated
09-07-2016
Reported
10-12-2016
Quantity
3,254 administration packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75253
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Biocompatibles U.K., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2017
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

60635-118-01 Varithena
60635-133-01 Varithena
60635-123-01 Varithena