"Eli Lilly 'FORTEO' Starter Kits Recalled Due To Triad Alcohol Pads Potentially Contaminated With Bacillus Cereus" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Lilly Announces Important Action Regarding Recall

of Alcohol Prep Pads Made by Triad Group Included in Forteo Starter Kits

This Recall Does Not Affect or Involve Forteo Delivery Device

Dear Ones:

     The Triad Alcohol pad recall situation continues to evolve.

     Now FORTEO (black) patient starter kits are involved since they include alcohol prep pads made by Triad.

     FORTEO is recombinant human parathyroid hormone analog (1-34), [rhPTH(1-34)] indicated for:
---Treatment of postmenopausal women with osteoporosis at high risk for fracture
---Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
---Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
     In English, this means that FORTEO is a synthetic parathyroid hormone-like compound which is used to encourage bone growth in the body.

"FOR IMMEDIATE RELEASE - March 17, 2011 - INDIANAPOLIS, March 17, 2011 – Eli Lilly and Company (NYSE: LLY) announced today 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 (sic) Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus (sic) cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. It is important to note that this recall does not affect or involve the Forteo Delivery Device. The starter kits did not contain the Forteo Delivery Device.
---Treatment of postmenopausal women with osteoporosis at high risk for fracture
---Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
---Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
     In 'English', this means that FORTEO is a synthetic parathyroid hormone-like compound which is used to promote bone growth.
     It is administered by injection via a 'multi-dose' device, hence the need for alchol pads.
Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
Some Forteo starter kits distributed by Eli Lilly and Company between March 2008 and June 2009 may have contained Triad Group alcohol prep pads. The Triad alcohol prep pads should not be used. The Forteo starter kits that contained the Triad alcohol prep pads were black bags and were discontinued in June 2009. The Forteo starter kits have been updated since June 2009. The bags are now blue, do not include Triad alcohol prep pads, nor any other alcohol prep pad.


Lilly has requested that physicians and their staff examine their inventory of Forteo starter kits and remove and appropriately discard the Triad Group alcohol prep pads in the black bags. Lil-ly has also requested that physicians inform any patients who may have received Forteo starter kits containing Triad Group alcohol prep pads to discontinue use of the pads.
Further information about this recall can be found at http://www.fda.gov/Safety/Recalls/ucm239219.htm1  For questions pertaining to the recall, consumers may contact Triad Group at 262-538-2900.


Adverse reactions or quality problems experienced with the use of the Triad alcohol prep pads may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.htm2
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm3
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 Fax: 1-800-FDA-0178
READ THE REST HERE: http://www.fda.gov/Safety/Recalls/ucm247596.htm
     And be sure to read all of my articles to date on the TRIAD ALCOHOL PREP PAD/SWABS/SWABSTICK Recall:
LINK: http://dearoneshealingministry.blogspot.com/p/triad-alc-pad-fda-recall.html
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/