Showing posts with label Pharmaceuticals. Show all posts
Showing posts with label Pharmaceuticals. Show all posts

Monday, January 9, 2012

'Huge Novartis Recall: Bufferin, Excedrin, Gas-X & NoDoz" By Rev. Barbara Sexton Dear Ones Healing Ministry

From the FDA:
"FOR IMMEDIATE RELEASE - Parsippany, January 8, 2012 Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

The affected bottle sizes are attached to this release. The Novartis Consumer Health Inc. Lincoln, NE facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA)."

"These over-the-counter products were distributed nationwide to wholesalers and retailers."

Here is a list of drugs affected by this recall:
This list includes the drugs highlighted above IN VARIOUS FORMS.  Be sure to check for yours!

"Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

For more information, please visit http://www.novartis-otc.com/otc/index.html "
Some Endo Pharmaceutical products (made by Novartis) are ALSO under investigation:
"FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product. The likelihood of this occurring in medication dispensed to patients is estimated to be low...Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up. Nonetheless, to ensure continued patient safety and access to these needed medicines, FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same. FDA and Endo are providing instructions on how to identify an incorrect tablet in these medicines.
Opiates are potent medications used to alleviate pain and are available only by prescription. The following Endo Pharmaceutical products1 disclaimer icon 2may be affected by the packaging problem (see also www.endo.com3):
  • Opana® ER (oxymorphone hydrochloride) Extended-Release Tablets CII
  • Opana® (oxymorphone hydrochloride) CII
  • Oxymorphone hydrochloride Tablets CII
  • PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
  • PERCODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
  • ENDOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
  • ENDODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
  • MORPHINE SULFATE Extended-Release Tablets CII
  • ZYDONE® (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
The likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low and patients should not be unduly alarmed. For medications already in homes and pharmacies, there are simple steps (see links below) that patients and healthcare professionals can take to identify whether they have any affected products.
Patients should follow the instructions provided by FDA4 and Endo5 disclaimer icon 6and look carefully at all of the pills in their pain medicine bottle. For any questions, patients should contact Endo Pharmaceuticals at1-800-462-3636 or ask their pharmacist or doctor for additional help in identifying whether there are any problems with their medication.
When dispensing a medication, pharmacists should perform a visual inspection according to the instructions provided by FDA7.
FDA is actively working with Novartis and Endo to address the manufacturing problems. Due to the problems that occurred when these products were packaged and labeled at the manufacturer, tablets from one product may have carried over into packaging of another product.
In the coming weeks we expect there will be periods of shortages for these products. FDA is working with Endo and Novartis to minimize the degree of impact. The degree of shortage will depend upon how quickly safeguards can be put in place to prevent this manufacturing issue from happening in the future and how soon manufacturing can be re-started.
Novartis has initiated a consumer level recall of the other non-opiate products made at their Lincoln, Nebraska manufacturing facility out of an abundance of caution for these other products. Please see the Novartis Press Release8 for more information.
FDA will update the public if this situation changes and more information is available."
LINK:  http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm
Please check what you have in your medicine cabinet.  Be sure to consult your pharmacist or physician to learn what is best for you!
Blessings,
Rev. Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com 

Tuesday, March 22, 2011

"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/

Friday, November 12, 2010

"This 'Robo-Nurse' Can Give You A Bath" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"


http://www.youtube.com/watch?v=0ac2qwStrdo&feature=player_embedded
Dear Ones:
     Leave it to Georgia Tech.  They've come up with a 'Robo-Nurse to beat the band which can give baths and can--presumably--'perform other tasks'.
     This 'CODY ROBOT' may actually be 'proficient' at certain things, but those 'old cold hands' just might leave much to be desired.
     Heaven knows patients need the HEALING TOUCH that only a REAL-LIFE HUMAN BEING--Nurse, Aide or Hands-On Healer-- can provide.  'Touch' has been proven over and over again to be necessary for all human (and animal) well-being.
     The lack of 'human touch' is but one of the problems with robot technology.  In fact, I'd go so far as to say that the metal and electronics of 'Robo-Nurse' might actually INTERFERE with human energy patterns and might therefore affect patients in adverse ways that the average clinician might never think of.
     In layman's terms, there are RISKS when medical care is reduced to 'mere technology'.  Traditional medical professionals may or may not realize this unless they have some training in 'alternative medicine'.  But even then, the 'coldness' of the doctor's office and surgical suite and those cold hands from so much 'gel sanitizing' (believe me I know...) can present quite an obstacle.
       We all know that nurses are the 'real healers' in the hospital--and sometimes the 'home'--setting.  There are more subtleties to healing than can be understood by medical science, and anyone wishing 'full service' needs to turn to not only the best that science and technology have to offer, but to 'real life, full-blown, bonafide' healers.
     As a biochemist who is also a Reverend and alternative health care provider, I heal by attending to the essences of both the physical and spiritual body. 
     If you've any 'doubt' about the existence of a 'spirit body', just ask any amputee with 'phantom limb pain'.  If you've any doubt about the value of 'spiritual healing', just ask any cancer survivor!
     Without a doubt, human interaction in medicine is as vital as the machines we 'make work'.  And the 'day' that any 'Robo-Anything' can do what I do is the day I hang up my shingle!...after a great deal of 'prayer', of course.
     Naturally, if one is interested only in expedient, impersonal, perfunctory performance, this one's for you.  But for those of us who really do 'believe in and value' warm-blooded person-to-person interaction....no thanks.
     The world will no doubt utilize these 'Robo-nurses' in tandem with robotic surgery for difficult situations.  I get that.  But what I am 'envisioning' is not pretty.
     Human nature being what it is, I can 'see' abortions and other 'unsavory procedures like euthanasia' being performed by machines...to the relief alternately of some health care providers, some health care proxies and even some patients, themselves.
     But 'true healers' will never go for this rogue use of robots.  We already live in a cyber-world.  We are already a part of the 'MATRIX' and we acknowledge that.
     What we 'can't' accept is the total disengagement from ethical and moral accountability by medical personnel. 
     Medicine simply cannot expect that it can relinquish it's direct responsibility for patient care without there being ramifications. 
     What a 'great excuse' physicians, nurses, techs, paramedics, physician's assistants, aides and alternative 'healers' will have if they are able to say, "It was the robot's fault.  It was 'the 'machine' who made that decision." 
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/
         

Thursday, August 12, 2010

'FDA Warns of Salmonella Risk From Frozen Rodents & Chicks Fed To Reptiles' By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

http://en.wikipedia.org/wiki/File:Tatar-1.jpg
Dear Ones:
      Ah, for the 'good old days' when Salmonella was an occasional problem with eggs and egg products.  Yes, there was a time when 'steak tartare' and 'raw egg health drinks' were in vogue and relatively safe to eat--BUT NO MORE!
     Please note this reptile food warning below.  The implication for us is realizing just how widespread Salmonella contamination of our poulty food stock really is.
     Don't be scared, just be careful, with you and your pets!
For you in Christ,
Rev. Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
FDA warns of Salmonella risk from frozen rodents fed to reptiles
The U.S. Food and Drug Administration is warning U.S. and international customers who may have purchased frozen mice from Biggers and Callaham LLC, doing business as MiceDirect, that these products, which are used as food for reptiles, have the potential to be contaminated with Salmonella...
The FDA is actively investigating positive Salmonella findings in frozen mice and environmental samples taken at the company’s Cleveland, Ga. plant. After it was informed of the positive samples, Biggers and Callaham voluntarily recalled all frozen mice, rats and chicks purchased between May 2009 and July 23, 2010. The frozen reptile feed was distributed in all states, except Hawaii, through pet stores and by mail order and direct delivery.

On Aug. 2, 2010, the Centers for Disease Control and Prevention (CDC) reported that 34 human illnesses in 17 states were associated with handling frozen rodents used for reptile food sourced from Biggers and Callaham. In general, snakes and other reptiles can harbor many strains of Salmonella for several years, but still appear healthy.
Frozen reptile feed was shipped in plastic bags with the following product codes M-SP100, M-P100, M-PF100, M-F100, M-H100, M-W50, M-A50, M-JA25, R-P100, R-F50, R-PUP50, R-W50, R-S50, R-M20, R-L10,R-J5, R-C5, R-M3 followed by E9, F9, G9, H9, I9, J9, K9, L9 or A10, B10, C10, D10, E10, F10, G10 and whole frozen chicks in 25 count bags.
The FDA advises customers with the contaminated product to place it in a sealed container in the trash so that no children, pets, or other animals, such as wildlife, may be able to reach it.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm221735.htm

Friday, March 19, 2010

BAD NEWS FOR ZOCOR USERS By Rev Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross" March 19, 2010

Dear Ones:
Please take care with this!
Blessings,
Rev Barbara Sexton
http://www.dearoneshealingministry.blogspot.com/
FDA NEWS RELEASE
For Immediate Release: March 19, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567; elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns about Increased Risk of Muscle Injury with Zocor
Highest approved dose of cholesterol-lowering medication could cause harm to muscles
The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, today’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury...read the rest here:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205215.htm 














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