Events

Recall of Device Recall Forteo teriparatide (rDNA origin) injection starter kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eli Lilly and Company.

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
    58219
  • Event Risk Class
    Class 2
  • Event Number
    Z-2191-2011
  • Event Initiated Date
    2011-03-17
  • Event Date Posted
    2011-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98738
  • 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, patient - Product Code KMJ
  • Reason
    Eli lilly and company announced 3/17/2011 that patients should not use the alcohol prep pads made by the triad group that are contained in the black starter kits for forteo [teriparatide (rdna origin) injection] in the united states.The tri-ad group is recalling the alcohol prep pads due to potential contamination with the bacteria, ba-cillus cereus, which could result in life threatening infecti.
  • Action
    The firm, Eli Lilly and Company, sent two letters entitled "URGENT MEDICAL DEVICE RECALL TRIAD GROUP ALCOHOL PREP PADS INCLUDED IN FORTEO STARTER KITS ALL ALCOHOL PREP PAD LOTS" to its customers. The first letter was dated March 18, 2011 and second follow-up letter was dated March 28, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to examine their inventory of Forteo starter kits; if they have any Forteo starter kits with a black bag, remove and appropriately discard the Triad Group alcohol prep pads; discontinue providing the product with the starter kits; inform any patients that may have received Forteo starter kits containing the Triad Group alcohol prep pads to discontinue use; note: after removing the Triad Group alcohol prep pads, all other components of the Forteo starter kits are acceptable for use: travel bag, pen case, gel packs, needles and instructional materials, and complete and return the enclosed business reply card. "It is important to note that this recall does not affect or involve the Forteo delivery device." For questions pertaining to the recall, contact Triad Group at 262-538-2900. (Please refer to the Triad Group press release issued on January 5, 2011 on the FDA website.) If you have product specific medical questions related to Forteo please call 1-800-LILLYRX.

Device

Device Recall Forteo teriparatide (rDNA origin) injection starter kits
  • Model / Serial
    This product is not lot coded and does not have an expiration date. The kits sucject to this recall were distributed between March 2008 and June 2009. Individuals who receive Forteo therapy are generally prescribed for a period of two (2) years.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Czech Republic, Germany, Slovak Republic, and Switzerland.
  • Product Description
    Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. || Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.
  • Manufacturer
    Eli Lilly and Company

Manufacturer

Eli Lilly and Company
  • Manufacturer Address
    Eli Lilly and Company, 1555 S. Harding/Lilly Corporate Center, Drop Code 2622, Indianapolis IN 46285-0001
  • Manufacturer Parent Company (2017)
    Eli Lilly & Company
  • Source
    USFDA