Showing posts with label FDA Recalls. Show all posts
Showing posts with label FDA Recalls. Show all posts

Tuesday, May 8, 2012

"UPDATE 5/23/12: List Of Dog Foods Recalled By FDA To Date Due To Salmonella Contamination" By Rev. Barbara Sexton 'The Biblical Biochemist-Where Science Meets the Cross'

courtesy  http://www.fda.gov/Safety/Recalls/ucm303920.htm
courtesy http://www.fda.gov/Safety/Recalls/ucm303371.htm

UPDATED: 5/9/12*
UPDATED: 5/14/12**
UPDATED: 5/23/12*** 
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Dear Ones:
     Here is an succinct and extensive LIST of the dog foods affected by the latest FDA Recall due to suspected Salmonella contamination.  
     Please understand that this list is a 'work-in-progress'.
     I will update it regularly for your convenience and for the well-being of your 'furry loved ones'.
     Be sure to check back frequently and visit the FDA links provided so that the safety of your pet may be assured via vigilance and swift action.
     Do 'err' on the side of caution with any suspected food and SEE YOUR VET IMMEDIATELY if your beloved pet exhibits any signs/symptoms of food-related illness whatsoever.
Thank you and God Bless You,
Rev. Barb
Apex Pet Foods
  • Apex Chicken and Rice Dog
CHECK YOUR APEX LOT NUMBERS HERE:
LINK:  http://www.fda.gov/Safety/Recalls/ucm303061.htm

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Canidae Pet Foods- Diamond Pet Food Gaston

  • Canidae Dog, All Life Stages
  • Canidae Dog, Chicken Meal & Rice
  • Canidae Dog, Lamb Meal & Rice
  • Canidae Dog, Platinum
CHECK YOUR CANIDAE LOT NUMBERS HERE:
LINK:  http://www.fda.gov/Safety/Recalls/ucm303063.htm

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Diamond Pet Foods
  • Chicken Soup for the Pet Lover’s Soul Adult Light Formula – dry dog food
CHECK YOUR CHICKEN SOUP FOR THE PET LOVER'S SOUL ADULT LIGHT FORMULA DRY DOG FOOD LOT NUMBERS HERE:
LINK:  http://www.fda.gov/Safety/Recalls/ucm302137.htm

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Diamond Pet Foods
  • Diamond Puppy Formula dry dog food
CHECK YOUR DIAMOND PUPPY FORMULA LOT NUMBERS HERE:
LINK: http://www.fda.gov/Safety/Recalls/ucm302514.htm 

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Diamond Pet Foods 
  • Diamond Naturals Lamb Meal & Rice
CHECK YOUR DIAMOND NATURALS LAMB MEAL & RICE LOT NUMBERS HERE:
LINK:  http://www.fda.gov/Safety/Recalls/ucm299606.htm

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Diamond Pet Foods
  • Chicken Soup for the Pet Lover’s Soul
  • Country Value
  • Diamond
  • Diamond Naturals
  • Premium Edge
  • Professional
  • 4Health
  • Taste of the Wild
  • Kirkland Signature Super Premium Adult Dog Lamb, Rice & Vegetable Formula (Best Before December 9, 2012 through January 31, 2013)
  • Kirkland Signature Super Premium Adult Dog Chicken, Rice & Vegetable Formula (Best Before December 9, 2012 through January 31, 2013)
  • Kirkland Signature Super Premium Mature Dog Chicken, Rice & Egg Formula (Best Before December 9, 2012 through January 31, 2013)
  • Kirkland Signature Super Premium Healthy Weight Dog Formulated with Chicken & Vegetables (Best Before December 9, 2012 through January 31, 2013)
  • Kirkland Signature Super Premium Maintenance Cat Chicken & Rice Formula (Best Before December 9, 2012 through January 31, 2013)
  • Kirkland Signature Super Premium Healthy Weight Cat Formula (December 9, 2012 through January 31, 2013)
  • Kirkland Signature Nature’s Domain Salmon Meal & Sweet Potato Formula for Dogs (December 9, 2012 through January 31, 2013)
Natural Balance Pet Foods
•  UPDATED 5/14/12** 5 LB Natural Balance Sweet Potato & Venison Dog UPC# 7-23633-88650-5
CHECK UPDATED 'BEST BY' NATURAL BALANCE SWEET POTATO & VENISON DOG FOOD DATES HERE:
LINK: http://www.fda.gov/Safety/Recalls/ucm303918.htm
15 LB Natural Balance Sweet Potato & Venison Dog UPC# 7-23633-88615-4       

28 LB Natural Balance Sweet Potato & Venison Dog UPC# 7-23633-88628-4       
 
5 LB Natural Balance Lamb Meal & Brown Rice Dog UPC# 7-23633-78755-0       

15 LB Natural Balance Lamb Meal & Brown Rice Dog UPC# 7-23633-78715-4       

28 LB Natural Balance Lamb Meal & Brown Rice Dog UPC# 7-23633-78728-4       

5 LB Natural Balance Sweet Potato & Bison Dog UPC# 7-23633-65553-8       

15 LB Natural Balance Sweet Potato & Bison Dog UPC# 7-23633-61718-5       

28 LB Natural Balance Sweet Potato & Bison Dog UPC# 7-23633-63031-3       

5 LB Natural Balance Vegetarian Dog UPC# 7-23633-80855-2       
Lot Code NBV1201 Best By Date: December 9, 2012
 
 • 28 LB Natural Balance Lamb Meal & Brown Rice Dog Large Breed Bites       
UPC# 7-23633-44443-9       

5 LB Natural Balance Lamb Meal & Brown Rice Dog Small Breed Bites       
UPC# 7-23633-42300-7      
12.5 LB Natural Balance Lamb Meal & Brown Rice Dog Small Breed Bites UPC# 7-23633-42301-4
UPDATED 5/23/12***
CHECK YOUR NATURAL BALANCE LAMB MEAL & BROWN RICE SMALL BREED BITED HERE:
LINK: http://www.fda.gov/Safety/Recalls/ucm304917.htm
CHECK YOUR NATURAL BALANCE LOT NUMBERS HERE:
LINK:  http://www.fda.gov/Safety/Recalls/ucm303042.htm
 
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Solid Gold Health Products for Pets, Inc. 
UPDATED 5/9/12*
  • WolfCub Large Breed Puppy Food
  • Solid Gold WolfKing Large Breed Adult Dog
CHECK YOUR SOLID GOLD HEALTH WOLFCUB PUPPY & ADULT DOG FOOD HERE:
  • Wellness Complete Health® Super5Mix® Large Breed Puppy
CHECK YOUR WELLNESS COMPLETE HEALTH Super5Mix HERE: LINK:  http://www.fda.gov/Safety/Recalls/ucm303039.htm

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

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 

Monday, January 2, 2012

"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"

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
      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

Tuesday, October 25, 2011

"The Source Of Listeria Contamination Of Cantaloupe-A Biochemist UPDATES It All" By Reverend Barbara Sexton 'The Biblical Biochemist-Where Science Meets the Cross"

Dear Ones:
     By now, you've probably had it 'up to HERE' with reports of tainted/contaminated foodstuffs.
     And I don't blame you if your eyes 'glaze over' with ennui as the 'lot of us' involved in gathering, analyzing and disseminating information drone on and on about the minutiae of various FDA Recalls...and what's being done to 'preserve the public's health'.
     But once in a while, the epidemiology 'shakes out' just beautifully and a coherent explanation exists for the situation under discussion.
     Such is the case with the Listeria monocytogenes contamination of cut and whole cantaloupe in the United States which has killed and which has sickened so many more.
     You will remember, from my previous article, that this is the very first time that Listeria-contaminated cantaloupe has been linked to food-borne illness in humans.
LINK: www.dearoneshealingministry.blogspot.com/2011/10/cantaloupe-listeria-contamination.html 
     Also you will recall that cantaloupe from Jensen Farms was distributed to the following states (and to no foreign countries that anyone is aware of):  
"FDA has verified that the following states received recalled cantaloupes directly from Jensen Farms: Arizona, Arkansas, Colorado, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Dakota, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Wisconsin and Wyoming. There is no indication of foreign distribution."
     Thus, what follows is a rare case of expert scientific study culminating in concrete evidence and conclusions which the public--meaning ALL of us--can use in a very real way to protect and preserve the lives and health status of ourselves and our loved ones.
     So here goes...
     On October 21, 2011, the FDA published a detailed report entitled, 
"Environmental Assessment: Factors Potentially Contributing to the Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of Listeriosis" which you can read at your leisure, for I will encapsulate the pertinent findings in it here, for you:
     Here are the basic findings of this FDA report:
1)  The positive 'swab cultures' collected at Jensen Farms DID match the types of Listeria found in the patients who were affected by this pathogen:
"Of the 39 environmental swabs collected from within the facility, 13 were confirmed positive for Listeria monocytogenes with pulsed-field gel electrophoresis (PFGE) pattern combinations that were indistinguishable from three of the four outbreak strains collected from affected patients. "
2)  Swab cultures positive for the Listeria in question was found all over the Jensen Farms operation: 
FDA Environmental Swabs Positive Results:
   Processing Line
9 positive samples from the grading belt
Swabs 21, 22, 23, 24, 26, 27, 29, 30 & 33
2 positive samples from the conveyor
Swabs 20 & 28
1 positive sample from the felt rollers
Swab 13
    Packing Area
1 positive sample from the conveyor belt
Swab 34
FDA Product Sample Results
1 Cantaloupe Sample collected from cold storage
5 subs tested positive
(10 whole cantaloupes or “Subs”)

LINK:  www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm#records
3)  The FDA has deduced how this Listeria outbreak at/from Jensen Farms originated:
"FDA identified the following factors as those that most likely contributed to the introduction, spread, and growth of Listeria monocytogenes in the cantaloupes:Introduction:
  • There could have been low level sporadic Listeria monocytogenes in the field where the cantaloupe were grown, which could have been introduced into the packing facility
  • A truck used to haul culled cantaloupe to a cattle operation was parked adjacent to the packing facility and could have introduced contamination into the facility
Spread:
  • The packing facility’s design allowed water to pool on the floor near equipment and employee walkways
  • The packing facility floor was constructed in a manner that made it difficult to clean
  • The packing equipment was not easily cleaned and sanitized; washing and drying equipment used for cantaloupe packing was previously used for postharvest handling of another raw agricultural commodity
Growth:
  • There was no pre-cooling step to remove field heat from the cantaloupes before cold storage. As the cantaloupes cooled there may have been condensation that promoted the growth of Listeria monocytogenes" 
LINK:  www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm#records
4)  The FDA once again emphasizes:
"FDA’s findings regarding this particular outbreak highlight the importance for firms to employ good agricultural and management practices in their packing facilities as well as in growing fields. FDA recommends that firms employ good agricultural and management practices recommended for the growing, harvesting, washing, sorting, packing, storage and transporting of fruits and vegetables sold to consumers in an unprocessed or minimally processed raw form."
5)  Considering the two-week shelf-life of cantaloupe, the FDA believes that ALL of the affected cantaloupe has been removed from the marketplace by Jensen Farm's voluntary recall of Sept. 14, 2011
6)  The final FDA consumer information is as follows:
"Listeria can grow at refrigerator temperatures, about 40 Fahrenheit (4 Celsius). The longer ready-to-eat refrigerated foods are stored in the refrigerator, the more opportunity Listeria has to grow.
It is very important that consumers clean their refrigerators and other food preparation surfaces. Consumers should follow these simple steps:
  • Wash hands with warm water and soap for at least 20 seconds before and after handling food.
  • Wash the inside walls and shelves of the refrigerator, cutting boards and countertops; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; dry with a clean cloth or paper towel that has not been previously used.
  • Wipe up spills in the refrigerator immediately and clean the refrigerator regularly.
Always wash hands with warm water and soap following the cleaning and sanitization process 
LINK: www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm#records
     So there you have it with this cantaloupe recall which, hopefully, will be ending shortly, although the FDA still considers this to be an open investigation.
     A warning letter has been sent to Jensen Farms 
LINK:  www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm276249.htm
and we have every expectation that things will be 'cleaned up'--literally--poste haste.
     But consider that this outbreak has been acknowledged to be the deadliest foodborne outbreak in the United States in more than 25 years.  There have been 123 cases and 26 deaths (which includes one miscarriage) reported to the CDC from 26 states.
LINK: www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/index.html
     And there are yet others who are pregnant and got ill and who are still being monitored.
     Therefore, we must not 'just hope'...but follow-up diligently and remain vigilante, so that no further food-borne illnesses occur due to Listeria contamination in cantaloupe or any other food.
LINK: www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM277070.pdf 
God Bless You 
Rev. Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com

Thursday, October 13, 2011

"Cantaloupe Listeria Contamination Problem Expands: A Biochemist Explains It All" By Rev. Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Dear Ones:
     Per the CDC, we are two and a half months into the latest Listeria outbreak in our food supply.
     This situation is significant because IT IS THE FIRST TIME CANTALOUPE HAS EVER BEEN IMPLICATED in a Listeria outbreak.
     All illnesses related to this event started 'on or after July 31, 2011'.
LINK: http://www.cdc.gov/listeria/outbreaks/index.html
     But this 'time frame' is somewhat amorphous, considering the 'lag period' between ingestion of contaminated melon and the development of...and reporting of...cases of listeriosis.  It may well be that the offending organisms have been at work infecting our cantaloupe supply for OVER FOUR and a half months, instead.
     Because it can take up to 2 MONTHS for listeriosis to develop after food contaminated with Listeria is consumed, you must understand that this FDA Recall is ONGOING.

LINK: http://www.cdc.gov/listeria/treatment.html
     The initial recall was for 'Jensen Farms' cantaloupes:
     "On September 14, 2011, FDA issued a press release to announce that Jensen Farms issued a voluntary recall of its Rocky Ford-brand cantaloupes after being linked to a multistate outbreak of listeriosis.
LINK: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm271899.htm
     However, the FDA and CDC pointed out that not all of the 'Jensen Farms' cantaloupe was readily 'identifiable' as it was distributed throughout the nation's food supply chain.
     And sure enough, on October 6. 2011, Fruit Fresh Up, Inc. brand cantaloupe and cut mixed fruit was added to the list of 'brands of cantaloupe' for consumers to AVOID:
"October 6, 2011 - Fruit Fresh Up, Inc. of Depew, New York is recalling approximately 4,800 individual packages of FRESH CUT CANTALOUPE AND CUT MIXED FRUIT CONTAINING CANTALOUPE because they have the potential to be contaminated with listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Fruit Fresh Up, Inc. was not advised of the possible contamination of the cantaloupe it acquired from an independent wholesale vendor until last Thursday, September 27th."
LINK: http://www.fda.gov/Safety/Recalls/ucm274835.htm
     New Yorkers, especially, will want to AVOID all of the following products by Fruit Fresh Up, Inc:
"The fresh cut fruit subject to this recall was sold between August 31, 2011 and September 11, 2011, and consisted of the following products: Cantaloupe Chunks, Cantaloupe Slices, Gourmet Fruit Salad, Small Fruit Salad, Small and Large Fruit Salad with Pineapple, Fruit Salad with Kiwi, and Fruit Trays."
     And REMEMBER (again) that the 'lag period' between ingestion of Listeria-contaminated produce and the development of signs and symptoms of listeriosis CAN BE AS LONG AS TWO MONTHS (8 weeks).
     So if you ATE any of these Fresh Fruit Up, Inc. products, be sure to see your health care provider IMMEDIATELY if you think you are developing what you believe to be any 'food-related' illness.  Check out the CDC's Listeriosis infection page for detailed information:
     It is plain to see that we are far from 'identifying' all the Listeria-contaminated cantaloupe that has been distributed to date.
     Indeed, the expert advice-which I cannot EMPHASIZE ENOUGH-is to exercise ALL CAUTION with eating ALL cantaloupe for the time being!:
"CDC recommends that consumers not eat whole or pre-cut Rocky Ford-brand cantaloupe from Jensen Farms. This is especially important for older adults, persons with weakened immune systems, and pregnant women...Even if some of the cantaloupe has been eaten without becoming ill, dispose of the rest of the cantaloupe immediately. Listeria bacteria can grow in the cantaloupe at room and refrigerator temperatures. Cantaloupes that are known to NOT have come from Jensen Farms are safe to eat. If consumers are uncertain about the source of a cantaloupe for purchase, they should ask the grocery store. A cantaloupe purchased from an unknown source should be discarded: "when in doubt, throw it out." 
LINK: http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/101211/index.html
     Did you get that, my dear Readers?  "WHEN IN DOUBT, THROW IT OUT".  And Rev. Barb advises that unless you are absolutely certain of a cantaloupe's 'origin', AVOID EATING IT AT ALL FOR THE TIME BEING!

     To date, 25 states are affected by this Listeria-contaminated cantaloupe:
" As of 9am EDT on October 11, 2011, a total of 116 persons infected with any of the four outbreak-associated strains of Listeria monocytogenes have been reported to CDC from 25 states.  The number of infected persons identified in each state is as follows: Alabama (1), Arkansas (1), California (1), Colorado (34), Idaho (1), Illinois (1), Indiana (3), Iowa (1), Kansas (7), Louisiana (2), Maryland (1), Missouri (4), Montana (1), Nebraska (6), New Mexico (13), New York (1), North Dakota (1), Oklahoma (11), Oregon (1), South Dakota (1), Texas (17), Virginia (1), West Virginia (1), Wisconsin (2), and Wyoming (3). "
LINK: http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/101211/index.html 
     As of October 12, 2011, 23 DEATHS and 1 miscarriage (not included in the deaths stat) have been reported to the CDC:
"Twenty-three deaths have been reported: 5 in Colorado, 1 in Indiana, 2 in Kansas, 2 in Louisiana, 1 in Maryland, 1 in Missouri, 1 in Nebraska, 5 in New Mexico, 1 in New York, 1 in Oklahoma, 2 in Texas, and 1 in Wyoming. In addition, one woman pregnant at the time of illness had a miscarriage." 
     For those interested in the more technical aspects of the Listeria contaminated FDA Recall, note the following:
"Listeriosis is caused by Listeria monocytogenes, a gram-positive bacillus common in the environment and acquired by humans primarily through consumption of contaminated food. Infection causes a spectrum of illness, ranging from febrile gastroenteritis to invasive disease, including sepsis and meningoencephalitis. Invasive listeriosis occurs predominantly in older adults and persons with impaired immune systems. Listeriosis in pregnant women is typically a mild "flu-like" illness, but can result in fetal loss, premature labor, or neonatal infection. Listeriosis is treated with antibiotics."
     'Febrile gastroenteritis' means fever and tummy ache and intestinal woes.  'Meningoencephalitis' refers to the brain and the membranes around the brain and the spinal cord (the 'meninges' pron men-IN-geez) being infected by the Listeria bacteria.
      It is a common practice and an essential 'tool' to 'subtype' pathogenic bacteria.  This is necessary to determine what bacteria are involved in an outbreak and can be critical to determining the transmission of--and eventually the original SOURCE of--the offending microbe.
     Most importantly, sub-typing allows health care providers to develop and administer an ideal antibiotic regimen for those who become infected.
     We all know by now that pathogens are those microbiological agents which cause disease, the most common of which known to the public are bacteria and viruses.
     In this case, "four widely differing PFGE pattern combinations and two serotypes (1/2a and 1/2b) have been associated with the outbreak strains of Listeria monocytogenes" (pron: list-TEAR-ee-ah mah-no-sye-TAHGE-en-eeze) were isolated from cut and whole cantaloupe samples collected from patients' homes, from grocery stores where Jensen Farms melons were sold and from the Jensen Farm, itself.
     The above report is from the 'Morbidity and Mortality Weekly Report' aka the 'MMWR', which is an 'arm' of the CDC (Centers for Disease Control and Prevention).
     PFGE is 'Pulsed Field Gel Electrophoresis' is a technology which allows a biochemist to apply a given sample to a 'gel matrix' wherein the specific components of the sample are 'separated' when a pulsed electric field (from several directions sequentially) is applied to it.
     PFGE is the technology that allows for 'DNA typing', for genetic 'fingerprinting' and for 'genotyping' any number of biological and natural ' moieties and has helped very effectively to distinguish between different Listeria sub-species.
     What happened with this Listeria-contaminated cantaloupe situation is that doctors and local and state health agencies reported cases of listeriosis to the FDA, which started studies of the situation.
     As in the case of infectious diseases, the CDC then became involved, for this Listeria contamination of cantaloupe has not 'gone away'.  Thus began the 'sample collection and analysis' as a collaborative effort between the FDA and the CDC...each doing what they do best.
     And, now, as you see MMWR is 'onboard' reporting on deaths and other 'outcomes' for consumers who have been infected with Listeria.
     So my advice for all of us is to be on guard here.  We are dealing with a yet-evolving and ongoing food-borne illness cluster, which is UNUSUAL and unprecedented in many ways:
"This outbreak has several unusual features. First, this is the first listeriosis outbreak associated with melon. Second, four widely differing PFGE pattern combinations and two serotypes (1/2a and 1/2b) have been associated with the outbreak. Third, this outbreak is unusually large; only two U.S. listeriosis outbreaks, one associated with frankfurters (108 cases) and one with Mexican-style cheese (142), have had more cases (1,2). Additional cases likely will be reported because of the long incubation period (usually 1--3 weeks, range: 3--70 days) and the time needed for diagnosis and confirmation. Fourth, this outbreak has the highest number of deaths of any U.S. foodborne outbreak since a listeriosis outbreak in 1998 (1). "
     I had not written on this outbreak Listeria in cantaloupe previously, thinking (and praying) that the media would have covered it adequately, you'd be informed and it would just run a 'limited course'.
     But Listeria-contamination of cantaloupe is NOT going away and we must be mindful of 'lag periods' in both disease manifestation and in reporting times.
     We also do not know, yet, if food processors are inadvertently contaminating OTHER foodstuffs with Listeria, and if so, what they may be.
     In an ideal situation, manufacturers 'cooperate' in FDA and CDC investigations, but this is not always the case, as I have written about before.
     So my best advice is to be aware of what you eat, AVOID what you should, be aware of your BODY and seek competent professional health care advice from a trusted health care provider at the first indication that something may be wrong.
     Anyone interested in the contamination of chopped Romaine lettuce with Listeria can read about that here:
May God Bless You & keep you healthy!
Rev. Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross
Receive Rev. Barb's FREE HEALTH NEWSLETTER-Sign Up Below
Questions/Comments:  Here below this article
       

Tuesday, October 4, 2011

"Listeriosis & The Lettuce Recall: A Biochemist Explains It All" By Rev. Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

ABOVE: Front & Back of Recalled chopped Romaine LETTUCE sold by retailers to the public at Unified Grocers, Inc. Cash & Carry Smart Food Service stores in Oregon, Washington, and Idaho. The product at those outlets was packed in True Leaf Farms cardboard cartons. All bags carry a "use by date" of 9/29/11. This product was labeled as follows:
  • 2# bags, chopped romaine- Bag and box code B256-46438-8 
Dear Ones:
     You can read the manufacturer's own recall statement here if you are interested:
LINK: http://www.churchbrothers.com/recall/True%20Leaf%20Farms%20Release.pdf
     I will 'break it down for you'...along with the FDA and CDC information available to us thus far.
      Here is the current, accurate information you need to help protect the health and well-being of yourself and your loved ones.
     Recently, both cantaloupe and now LETTUCE has been recalled due to contamination with the bacteria known as Listeria monocytogenes (pronounced: list-TEAR-ee-ah  mah-no-sye-TAHGE-en-eeze).
    Here is the latest FDA recall list in an easy-to-view format for both the melon and LETTUCE:
LINK: http://www.fda.gov/Safety/Recalls/default.htm
(NOTE:  If any of these FDA/government LINKS do not work directly, just copy and paste them into your browser to access.) 
     As this is being written, no actual illnesses have been reported as being linked to the True Leaf Farm brand LETTUCE found to be contaminated with Listeria monocytogenes
LINK:  http://www.fda.gov/Safety/Recalls/ucm274075.htm
     BUT, while the original LETTUCE recall was limited to Oregon, Washington and Idaho, per the FDA, now as of Sept 29, 2011, the recall notification is EXPANDED to cover product shipped to 19 states (highlighted below and CANADA):
"September 29, 2011- True Leaf Farms is expanding its voluntary recall of romaine to include 2,498 cartons of chopped or shredded romaine because of the potential of contamination with Listeria monocytogenes. The initial recalled product was shipped between September 12 and 13 to a retail food service distributor in Oregon who further distributed it to at least two additional states, Washington and Idaho.
At the request of the US Food and Drug Administration the recall notification is expanded to cover additional product shipped to wholesale food service distributors in 19 states and Alberta, Canada. The states include Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Minnesota, Missouri, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee and Vermont. All the romaine affected by this recall has a "use by date" of 9/29/11.
No illnesses related to this finding have been reported."
      True Lead Farms is 'the processing arm' of Church Brothers, LLC.  They process LETTUCE  under the following brand names under 'Church Brothers':
True Leaf, Red Coach, Jin Ye, Hop Sing & Private Labels.
     Under 'True Leaf', the Church Brothers, LLC sell under the following brand names: True Leaf, Church Brothers, Leaf Tek & Private Labels.
LINK:   http://churchbrothers.com/content/?page_id=851
     Besides chopped Romaine LETTUCE, Church Brothers, LLC also processes and packages: Broccoli, lettuce, Red leaf, Butter, Baby Heads, Spinach, Endive, Escarole, Cauliflower, Celery, Green Cabbage, Red Cabbage, Bok Choy, Nappa Cabbage, Green Onions, Cilantro, Parsley, Italian Parsley, Kale & 'Specialty Items'.
LINK:  http://churchbrothers.com/content/?page_id=128
     A comprehensive  government page for Listeria and listeriosis can be found here:
LINK:  http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/listeria/index.html
     A general page on Listeria and listeriosis on the CDC website is below:
LINK:  http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/listeria/
     Please do take the time to read as much of the 'original sources' as you can.  (AGAIN: copy and paste any of the links here if they do not take you to the desired page directly.)
     But for your convenience and edification, these are Rev. Barb's recommendations at the present time regarding this Church Brothers, LLC Listeria romaine LETTUCE contamination:
1)  Absolutely avoid any and all chopped romaine LETTUCE 'processed' by Church Brothers, LLC/True Leaf until the full extent of this contamination is definitively determined.

2)  Check the 'brand names' of all the produce you buy against 'brand name lists' published on the FDA and CDC websites and here ABOVE at www.DearOnesHealingMinistry.blogspot.com/  Check back here regularly for UPDATES on this LETTUCE situation, as well as for articles on the cantaloupe contamination, as well.

3)  Even if your state is not listed above, be aware that not all distributions patterns of this fresh produce have necessarily been determined, let alone revealed to the public.

4)  Although NO ILLNESSES TO DATE have been associated with this chopped Romaine lettuce contaminated with Listeria, maintain a 'high index of suspicion' until the full epidemiological study is completed for this FDA Recall.  Be sure to see your health care provider IMMEDIATELY if you suspect that you may have a food-related illness and/or symptoms of the same.  DO NOT DELAY, especially with the young, the old and with those who are immunocompromised.

5)  Although, to date, only chopped Romaine LETTUCE from Church Brothers, LLC/True Leaf Farms has been determined to be contaminated with Listeria monocytogenes, be aware that their other products MAY also be contaminated.  See the yellow highlighted list of vegetables above. 

6)  Since we, the consumer, does not know exactly what Church Brothers, LLC/True Leaf Farms' 'Specialty Products' are, be wise when you purchase your produce and take care to know determine the source of the food you and your family and friends eat.

7)  Although only RETAIL chopped Romaine LETTUCE is implicated in this Listeria Recall so far, be wary of 'bulk salad and vegetable' points of purchase, such as at 'salad bars' and in restaurants and other food-selling facilities.  Use your COMMON SENSE, but also check online frequently using the LINKS you have been provided with here.

8)  In this day-and-age of questionable food safety, take care to wash and scrub the vegetables and fruits you can (I prefer warm watch and dish detergent followed by a strong water rinse)...And to give a good 'soaking and rinsing' for those that cannot be 'scrubbed'.  Please note that with Listeria, it is possible that the 'inside' can be contaminated, so that even a good scrubbing on the outside will not necessarily assure consumer safety.  Chopped Romaine LETTUCE has it's own particular set of problems sanitation-wise, since it cannot be scrubbed, subjected to too-warm water and it has the further 'detriment' of having been handled more than the intact stalk of Romaine would be.  In addition, the 'chopping process' greatly increases the available surface area for potential bacterial contamination wherever pathogenic bacteria are present.

9) Finally, it is prudent to 'rotate food'.  In other words, try not to eat the same thing day-after-day, even if the food you are eating will be prone to spoiling before you can finish it.  "Greens" nowadays can be every bit as deadly when contaminated as the rawest of meats and other foodstuffs capable of causing food-poisoning.
     Hopefully, this Listeria contamination source will be swiftly identified and dealt with.
     But, until then, stay alert and informed.  If you would like to receive Rev. Barb's FREE NEWSLETTER so that you can receive timely health alerts right in your mailbox, just see the sign-up area below.
God Bless & Keep You & All Of Us
Rev. Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com

Thursday, June 30, 2011

"McNeil's Quality Control 'STINKS' As Much As Its Tylenol Products Do" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"



Dear Ones:
     For a while now, we've been observing various problems with the McNeil company and their 'Tylenol', 'Benadryl', 'Zyrtec' and other brand lines.
     'Dust' in the facility, lacking or insufficient testing protocols, 'particulate matter' in their liquid products, 'off and moldy smelling products', 'superpotent' drugs, drugs with 'inactives' which haven't been properly tested, the use of raw materials known to be contaminated with gram negative bacteria...
LINK:  www.dearoneshealingministry.blogspot.com/2010/05/mcneil-childrens-drugs-fda-recall-camp.html

LINK:  www.dearoneshealingministry.blogspot.com/2010/05/fda-childrens-tylenol-recall-mcneil.html

LINK:  www.dearoneshealingministry.blogspot.com/2010/05/mcneil-tylenol-motrin-zyrtec-benadryl.html 

     The list of poor or lacking quality controls and assurances from McNeils goes on and on.
LINK: www.tylenol.com/page.jhtml?id=tylenol/news/main.inc

     Likewise "Good Manufacturing Practices' is something this company just cannot seem to wrap it's 'corporate culture' around and we are left to wonder why.
     Do they truly care so little for the consumer and so much for the almighty dollar that they consistently fail to assure us that their products are safe to use?
     We'll not find the answer at this time, but instead turn to a discussion of this 'stinky tablet' problem.
     In a sentence, 'skids' (also known as 'pallets') are wooden platforms upon which cases of 'finished product' are stacked prior to bulk 'shrinkwrapping'.
     The skids are picked up by fork-lifts and carried into large trucks for shipping all over the place.
     Skids can be made of either wood (the traditional way) or of compressed, molded recyclable plastic.
     Naturally, the 'wood ones' require some kind of preservative, as all wood does, in order that the wood maintain it's integrity and, therefore, it's strength.  The way to do this is to apply a suitable fungicide to the skids at the place they are manufactured.
     Fully loaded skids are heavy indeed.  If a skid 'collapses', it must be unloaded in place, which can be both a nuisance, and which can be dangerous if it blocks the flow of floor traffic.
     But the real danger is that it can cause it's load's center-of-balance to shift, thus causing it to become 'top-heavy' and come tumbling down, Heaven forbid, on a hapless warehouse worker or materials handler or passer-by!
     I mention this in order to emphasize how important it is to maintain 'good warehousing practices' at all times.
     The substance generally used for 'skids' is a stinky chemical known as TBA, which stands for 2,4,6-tribromoanisole.
     The best description I can give of it is that it smells like 'concentrated essence of vomit'  topped off with a good dollop of 'eau de dirty underwear'.
     Anyone familiar with warehouses knows how unpleasant it is to get a shipment of ANYTHING on 'new skids' in house.  You've got to keep the bay doors open and fans going in order to get that stink out...and it takes weeks, if not longer, for the smell to ever settle down.
     In fact, the most popular 'game played' is to get those 'new skids' out the shipping door as fast as possible so that some OTHER warehouse can have them while they 'age into respectability of smell'...not that anyone will actually admit they do this!
     Temperature is a factor, of course.  In the summer, it can get really bad in a non-temperature controlled facility with those stinky skids, on loading docks and in hot trucks.
     And the heat makes it all the more likely that anything placed on those skids will absorb the 'off odor' like crazy.
     Add to that that the packaging materials used (primarily plastic and paper) for most drugs and pharmaceuticals ALSO absorb 'off odors' easily.  AND on top of that, the 'final packaging' often involves heat processes (i.e. safety seals and shrink wrapping of all sorts) and you can imagine that you can have a real 'stinker' on your hands.
     And, wait, there's more!
      In certain instances, jars/bottles of non-tableted drugs and cosmetics are bottled or put in jars while still warm, which only prolongs the 'cool-down' period, and then you have real potential for the consumer to have a very unpleasant surprise when they finally open up their package.
     No doubt, the 'musty/moldy' odor in the Extra Strength Tylenol Caplets below came to be as a result of what I have just discussed above.  McNeil is no different than any other manufacturer when it comes to dealing with such issues.
     It is not uncommon to have to DEAL WITH odor issues, but it is UNACCEPTABLE to put such affected product out to market!
     And any concern who swears they 'didn't realize they had a problem'...needs to have their 'noses' examined!
     You will be told that, (although the odor is offensive) "the risk of serious adverse medical events is remote".
     This is true, although the TBA (2,4,6-tribromoanisole) itself most certainly is NOT.
     This benzene derivative is toxic and carcinogenic in the quantities skid manufacturers, chemists and others are likey to be exposed to.
     And a hot warehouse-full of smelly skids can definitely make one sick to one's stomach, as well as producing respiratory issues for those exposed to such a stench.
     That the McNeil people continue to have these 'off-odor' problems on top of all their other Q.C./Q.A. issues only reveals an entity that is NOT vitally concerned about the health and well-being of their customers...let alone their poor employees.
May God Bless & Keep You All
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com 


      McNeil Consumer Healthcare Announces Voluntary Recall Of One Product Lot Of TYLENOL® Extra Strength Caplets 225 Count Distributed In The U.S.

Contact:
Consumer:
1-888-222-6036
Media:
Marc Boston
215-273-7649 (office)
215-429-7034 (mobile)
Bonnie Jacobs
215-273-8994 (office)
856-912-9965 (mobile)
FOR IMMEDIATE RELEASE - June 28, 2011 - Fort Washington, PA – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling at the retail level one product lot (60,912 bottles) of TYLENOL®, Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recalled product was manufactured in February, 2009. McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).
This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.
The product lot number for the recalled product can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
Product Name Lot Number UPC Code
TYLENOL®, Extra Strength Caplets, 225 count ABA619 300450444271
 
Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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