Events

Recall of Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. || Sold under the following brand names: || Family Dollar || HomeBest || HEB || Meijer || Food Lion || health PRIDE || Stop and Shop || Super G || sunmark || Brite-Life || Wegmans || Our Family || Healthy Generations || GoodSense || Winn Dixie || Finast || Western Family || K C Pharmaceuticals

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by K C 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
    30216
  • Event Risk Class
    Class 2
  • Event Number
    Z-0060-05
  • Event Initiated Date
    2004-10-04
  • Event Date Posted
    2004-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35412
  • 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
    Accessories, Soft Lens Products - Product Code LPN
  • Reason
    Routine testing indicates product does not meet the expiration date in all cases.
  • Action
    Product is being recalled due to concern that the product does not meet it's expiration date. Firm sent letters to it customers requesting them to remove product from stores and to destroy it. A destruction form was sent with a request to mail it back.

Device

Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. |...
  • Model / Serial
    All Codes
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. || Sold under the following brand names: || Family Dollar || HomeBest || HEB || Meijer || Food Lion || health PRIDE || Stop and Shop || Super G || sunmark || Brite-Life || Wegmans || Our Family || Healthy Generations || GoodSense || Winn Dixie || Finast || Western Family || K C Pharmaceuticals
  • Manufacturer
    K C Pharmaceuticals Inc

Manufacturer

K C Pharmaceuticals Inc
  • Manufacturer Address
    K C Pharmaceuticals Inc, 3220 Producer Way, Pomona CA 91768-3915
  • Source
    USFDA