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

photo courtesy http://www.pharma.us.novartis.com/info/about-us/index.jsp

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)."

LINK: http://www.fda.gov/Safety/Recalls/ucm286240.htm

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

LINK: http://www.fda.gov/Safety/Recalls/ucm286240.htm

Here is a list of drugs affected by this recall:

LINK: http://www.fda.gov/downloads/Safety/Recalls/UCM286242.pdf

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:

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm .
  Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
• Fax: 1-800-FDA-0178

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 products^{1 2}may 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 Endo^{5 6}and 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 

"If You Use Birth Control Pills, You Need To Be Aware Of This New Years Surprise" By Rev. Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

 courtesy http://www.webweaver.nu/clipart/new-years/3.shtml

Dear Ones:

     Sometimes, health-related situations arise which demand our immediate attention.

     Such is the case here, with a birth control 'pill' FDA Recall 'in-progress'...which is listed in the December 28, 2011 FDA 'Enforcement Report'.

     The FDA, itself, recognizes that there may be unintended consequences for those who use certain drugs during the interim period between the issuance of an 'Enforcement Report' and the actual 'RECALL' of the pharmaceuticals under discussion.

     I am not a fan of oral birth control pills- not so much from a 'moral perspective', but, rather, because there are very real health consequences to long-term users of these drugs.

     What I present here is purely from a scientific perspective as a biochemist.  You know the negative side-effects of your oral birth control methods, ladies.  Unfortunately, in this case, you can add an 'increased likelihood of unintended pregancies' due to packaging errors!

     Rev. Barb's advice: the shorter the duration of 'pill' use, the better.  Also, remember that oral contraceptives do NOTHING to protect you against STD's of all sorts.

     That being as it may,  here's a recent official FDA statement regarding 'RECALLS' currently suspended in a bureaucratic 'limbo':

"The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report¹⁷, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov." (Enforcement Report December 28, 2011

LINK: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm285341.htm

      What this MEANS is that the FDA, (and I agree) feel that the public really ought to be notified ASAP about pending drug RECALLS even before the official weekly report comes out and even before a particular RECALL is officially 'classified' ("I, II or III").
     I have chosen here to highlight 3,220,845 cards of oral contraceptives distributed nationwide and in Puerto Rico, since the stated reason these pills are in the process of being recalled is as follows: "Contraceptive Tablets Out of Sequence; blister cards were rotated 180 degrees, reversing the weekly tablet orientation."  (Enforcement Report Dec. 28, 2011)
LINK:  http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm285341.htm

     And we all know what that means.
     You can be as responsible as you can and there will still be no way that you can be assured of the stated efficiency and efficacy of your favored birth control method.
     Be sure to check for your birth control brand...and check out the other pending RECALLS of other drugs in the Enforcement Reports.  Brand names of the affected oral contraceptives include Cyclafem, Emoquette, Gildess, Orsynthia, Previfem and Tri-Previfem. 
LINK: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm285341.htm
     I applaud the FDA for featuring the information the public needs to see more prominently, as highlighted in their pilot program statement above.
     It's tough for patients to stay up-to-date as it is.  All of us can use all the help we can get when it comes to the health of ourselves and our loved ones.
     Here's the FDA Homepage LINK: http://www.fda.gov/default.htm
     You will find all FDA RECALLS & Enforcement Reports and other information there...and you should 'bookmark' it for future reference.
     And, of course, be sure to consult your personal health care provider for specific advice for you.

For Your Health & Happiness

God Bless You this New Year

Rev. Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com

"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/