Recall Z-2191-2011 ยท KMJ Lubricant, Patient
Eli Lilly and Company
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.
| Date | May 12, 2011 (initiated Mar 17, 2011) |
| Status | Terminated |
| 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 |
| Root 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 w |
| Quantity | approximately 47,000 kits |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Czech Republic, Germany, Slovak Republic, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.