Events

Recall of Euflexxa (1 sodium hyaluronate)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ferring Pharmaceuticals Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55407
  • Event Risk Class
    Class 3
  • Event Number
    Z-1635-2010
  • Event Initiated Date
    2010-04-16
  • Event Date Posted
    2010-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90770
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Acid, hyaluronic, intraarticular - Product Code MOZ
  • Reason
    Out of specification results for molecular weight or viscosity through the established expiration date.
  • Action
    Ferring Pharmaceuticals issued a "Medical Device Recall" notification dated April 16, 2010 by Federal Express to all distributors, retail pharmacies and physicians who received the product. Consignees were asked to stop distribution, return affected product to the firm and fax a completed Product Inventory Form to the firm. For further information, contact Ferring Pharmaceuticals at 1-973-796-1600 or via fax at 1-973-796-1660.

Device

Euflexxa (1 sodium hyaluronate)
  • Model / Serial
    Lot Numbers: RC0101A, Exp. 5/2010; RC0102A, Exp. 5/2010; RC0107A, Exp 5/2010; RC0114A, Exp 5/2010; RC0118A, Exp 6/2010; RC0122A, Exp 6/2010; RC0123A, Exp 6/2010; RC0127A, Exp 6/2010; and RC0131A, Exp 6/2010.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; || Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. || Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
  • Manufacturer
    Ferring Pharmaceuticals Inc

Manufacturer

Ferring Pharmaceuticals Inc
  • Manufacturer Address
    Ferring Pharmaceuticals Inc, 4 Gatehall Dr Fl 3rd, Parsippany NJ 07054-4518
  • Manufacturer Parent Company (2017)
    Ferring Holding S.A.
  • Source
    USFDA