Events

Recall of Dr. Sheffield's LUBRI GEL

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

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
    71129
  • Event Risk Class
    Class 2
  • Event Number
    Z-1953-2015
  • Event Initiated Date
    2015-04-27
  • Event Date Posted
    2015-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136174
  • 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
    Lubricant, vaginal, patient - Product Code MMS
  • Reason
    Recovery of high count of gram positive rods including single colonies of b. cepacia.
  • Action
    A letter was sent to inform customers of the voluntary recall of Sheffield Pharmaceuticals Lubri-Gel Personal Lubricant Jelly. The letter described the issue and asked customers to quarantine all related inventory immediately and provide their inventory counts on the specific lots. Questions or concerns related to the recall or letter can be directed to James Turner at James.Turner@sheffield-pharmaceuticals.com.

Device

Dr. Sheffield's LUBRI GEL
  • Model / Serial
    Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.
  • Product Description
    Dr. Sheffield's LUBRI GEL 3 oz (85 g) || Non sterile over-the-counter personal lubricant.
  • Manufacturer
    Sheffield Pharmaceuticals, LLC

Manufacturer

Sheffield Pharmaceuticals, LLC
  • Manufacturer Address
    Sheffield Pharmaceuticals, LLC, 170 Broad St, New London CT 06320-5313
  • Manufacturer Parent Company (2017)
    Sheffield Pharmaceuticals Llc
  • Source
    USFDA