Class 2 Device Recall Forteo teriparatide (rDNA origin) injection starter kits

• Date Initiated by Firm: March 17, 2011
• Date Posted: May 12, 2011
• Recall Status: Terminated on August 30, 2011
• Recall Number: Z-2191-2011
• Recall Event ID: 58219
• Product Classification: Lubricant, patient - Product Code KMJ
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Eli Lilly and Company; 1555 S. Harding/Lilly Corporate Center; Drop Code 2622; Indianapolis IN 46285-0001
• For Additional Information Contact: 317-276-4000
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Material/Component Contamination
• 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.
• Quantity in Commerce: approximately 47,000 kits
• Distribution: Worldwide distribution: USA (nationwide) and countries of: Czech Republic, Germany, Slovak Republic, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.