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
  • 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
  • 1 Event

Manufacturer

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