Showing posts with label recalls. Show all posts
Showing posts with label recalls. Show all posts

Saturday, June 2, 2012

FDA issues health warning to veterinarians, pet owners about chicken jerky

A dog owner in the Chicago area has filed a class action lawsuit alleging
that his 9-year-old Pomeranian died as a result of eating Nestlé Purina¹s
Waggin¹ Train Yam Good dog treats. The fatality and resulting lawsuit are
the most recent in a series of events illustrating the public¹s growing
anxieties over an apparent connection between chicken jerky treats from
China and a surge of unexplained illness in dogs.

According to the lawsuit, filed on April 18 in U.S. District Court for the
Northern District of Illinois by Dennis Adkins of Orland Park, Ill., the dog
became ill and died of kidney failure less than two weeks after consuming
the treats in March. Adkins says he gave one of the treats to his dog daily
for two days and that no other changes were made to the dog¹s diet. His
other Pomeranian was not fed the treats and did not become ill. The suit
names as defendants Waggin¹ Train LLC, the manufacturer of the product;
Nestlé Purina Petcare Co., the corporation that owns Waggin¹ Train LLC; and
Wal-Mart Stores, Inc., the distributor.

The lawsuit states that although Nestlé Purina and Waggin¹ Train had
received complaints of more than 500 incidents in which dog treats
containing chicken jerky imported from China caused dogs to become sick or
die, they continued to market their product as being ³wholesome² and placed
no warnings concerning the product on the packaging. Additionally, it states
that Nestlé Purina and Waggin¹ Train knew there was a substantial risk of
death or harm associated with its dog treats and intentionally concealed
known facts concerning the safety of the dog treats in order to increase or
maintain sales.

Keith Schopp, spokesperson for Nestlé Purina and Waggin¹ Train, states, ³We
believe the claims made in the lawsuit to be without merit and we intend to
vigorously defend ourselves. We can say that Waggin¹ Train products continue
to be safe to feed as directed.²

The lawsuit brings eight counts against the defendants by Adkins and on
behalf of all consumers who purchased the chicken jerky dog treats. The
allegations include breach of implied and express warranty, consumer and
common law fraud, unjust enrichment, negligence, and strict products
liability with defective design or manufacture and failure to warn. Adkins
is seeking an excess of $5 million for compensatory and punitive damages and
costs of the suit.

The case is just one of many reported incidences of illness in pets in
association with the consumption of chicken jerky products. Numerous
complaints concerning Waggin¹ Train chicken jerky treats sickening or
killing dogs can be found on the Internet and have sparked the creation of
petitions and social media groups by and for pet owners who have lost their
pet to illness that they believe is associated with the treats.

Dating back to 2007, the U.S. Food and Drug Administration (FDA) has been
investigating a potential connection between the illnesses reported and the
treats and has tested a number of samples for contaminants and toxins.
However, according to the FDA, scientists have been unable to determine a
definitive cause for the reported illnesses. Unless a contaminant is
detected and there is evidence that a product is adulterated, the FDA is
limited in the regulatory actions it can take.

The FDA did issue cautionary warnings to the public concerning chicken jerky
treats in September 2007 and issued a Preliminary Animal Health Notification
in December 2008. The number of complaints declined during the latter part
of 2009 and most of 2010, the agency reports, but an increase in consumer
complaints prompted the FDA to issue a cautionary update again in November
2011. Since that issuance, there has been a steady rise in complaints
regarding the chicken jerky products,with more than 900 cases reportedly
affected by consumption of these treats, the FDA says.

No recalls have been issued for Waggin¹ Train or any brand of chicken jerky
treats to date. On the company¹s web site, Waggin¹ Train addresses consumer
concerns and continues to maintain the integrity and quality of their
chicken jerky treats, asserting a comprehensive food safety program and
strict quality assurance teams dedicated to overseeing the various steps of
the manufacturing process.

Despite the absence of a formal recall, the FDA recommends that pet owners
monitor their dogs closely for signs of illness if they choose to feed
chicken jerky treats. Symptoms of disease include vomiting, lethargy and
anorexia, and based on preliminary data, the problem appears more likely to
occur in small-breed dogs that are fed the treats regularly or in amounts
exceeding the labeled feeding recommendations. Veterinarians who suspect a
pet illness associated with the consumption of chicken jerky treats are
urged to report the case to the FDA immediately.

Related Links
FDA issues health warning to veterinarians, pet owners about chicken jerky
products from China
http://veterinarynews.dvm360.com/dvm/Veterinary+news/FDA-issues-health-warning-to-veterinarians-pet-own/ArticleStandard/Article/detail/749800>

More complaints; more caution from FDA about chicken jerky products for dogs
http://veterinarynews.dvm360.com/dvm/Veterinary+news/More-complaints-more-caution-from-FDA-about-chicke/ArticleStandard/Article/detail/572912>
 

Diamond Pet Food Recall Expands

Diamond pet food recall expands again, violations found
Philadelphia Inquirer (blog)
In the current situation, this dog food, which was produced in South
Carolina, was recalled nationally by the manufacturer in cooperation with
the FDA. A day later the Health Department issued a warning about
contaminated shellfish that may or may not ...
<http://www.philly.com/philly/blogs/pets/153150915.html>

Multiple failures cited at Diamond Pet Foods facility
DVM 360
The US Food and Drug Administration (FDA) recently released a preliminary
inspection report of Diamond Pet Foods' Gaston, SC, production plant, which
was linked to the company's massive pet food recall in April. The recall was
initiated after the ... ...
<http://veterinarynews.dvm360.com/dvm/Veterinary+news/Multiple-failures-cite
d-at-Diamond-Pet-Foods-facil/ArticleStandard/Article/detail/774745?contextCa
tegoryId=378>

Diamond adds cat food to the growing list of recalled pet foods because of
...

Pet Food Recall

Nestlé Purina Petcare has issued a voluntary recall of one lot of its Purina
Veterinary Diets OM Overweight Management canned cat food in response to a
customer complaint received by the FDA. This specific brand of cat food is
only available for purchase through veterinarians in the United States and
Canada. Analytical testing of the product by the US Food and Drug
Administration (FDA) has revealed low levels of thiamine (vitamin B1).

Cats eating this specific lot of the food for several weeks are at risk for
developing thiamine deficiency. Thiamine is essential for cats. Early signs
of thiamine deficiency in cats include decreased appetite, salvation,
vomiting, and weight loss. Advanced symptoms may include signs of the neck
bending towards the floor, wobbly walking, falling, circling, and seizures.
However, if treated promptly by a veterinarian, thiamine deficiency is
usually reversible.

Only cans with the following information are affected by the voluntary
recall: Can Size: 5.5oz, ³Best By² Date: June 2013, Production Code:
11721159, Can UPC code: 38100-13810. No other Purina pet food products are
included in this recall.

³EMSL Analytical tests for numerous vitamins, including all forms of vitamin
B,² states Shannon Kauffman, Food Chemistry Lab Manager. ³Our vitamin
analysis is compliant with FDA regulations, and RDI and DV percentages can
be provided when applicable.²

For more information about EMSL¹s food testing division, please contact EMSL
at 800-220-3675, email info@EMSL.com, or visit www.EMSL.com or
www.foodtestinglab.com.

About EMSL Analytical, Inc.
EMSL Analytical is a full service testing company providing quality lab
services under the same private ownership since 1981. Including the
corporate lab facility in Cinnaminson, NJ, EMSL Analytical operates over
thirty laboratories nationwide in the US and Canada. We provide analytical
services for environmental, indoor air quality (IAQ), industrial hygiene,
forensics and materials science, consumer products, food safety, PCR,
pharmaceutical, asbestos, lead, and radiological samples. The company has an
extensive list of accreditations from leading organizations, as well as
state and federal regulating bodies. Please see our website for a complete
listing of accreditations.
 

Sunday, January 24, 2010

Pet drug alert: FDA widens recall,but has it done enough?

Christie Keith writes a disturbing story on PetConnection.com about the slowdissemination of information about common drugs used by veterinarians duringsurgeries. If you're a pet owner, you'll want to ask your vet if he usesthese drugs. Keith compares this debacle to the 2007 recall of pet food. Keith writes that the Federal Drug Administration does not have theauthority to do a mandatory recall on drugs and the distributors of thedrugs were under no obligation to contact veterinarians. More pets died as aresult. The two drugs are Butorphanol and Ketamine, often used as part ofthe anesthia during dental cleaning. Readers: Spread the word. Someone needs to do that job! Do you ever questionwhat drugs your veterinarian is using? She writes: This complaint probably sounds familiar to anyone who remembers the 2007 petfood recall, when questions about who made your pet's food, and whether anyof its ingredients came from China, were impossible to determine fromreading the label. The 2007 pet food recall was also marked by enormous problems in obtaininginformation from the FDA. Many journalists and bloggers, including me,regularly reported recalls that the FDA did not announce until days or evenweeks later -- a scenario that's playing out all over again today. Entire story:
http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2010/01/13/petscol011310.DTL


Your Whole Pet - Christie Keith Major veterinary drug recall gets bigger Animal anesthetic drug pulled off market, but questions remain By Christie Keith, Special to SF GateWednesday, January 13, 2010 What if your veterinarian was using a recalled drug -- and didn't know it? That's not a hypothetical question. On Sept. 4, at least two veterinarydrugs made by Teva Animal Health, Inc., a division of Israeli-based TevaPharmaceutical Industries, were recalled by the FDA, which shut the companydown in July. But few veterinarians or pet owners were aware of the recalluntil the end of December. Although the reported deaths of five cats led the FDA to issue public recallnotices on Dec. 22 and Dec. 29, just what products are involved, and overwhat time period they were manufactured and sold, remains unclear. The recalls involve two commonly used injectable veterinary drugs:butorphanol, a fast-acting opioid used to control pain from surgicalprocedures in dogs and cats, and the anesthetic agent ketamine. Ketamine is part of a "cocktail" of drugs that induces anesthesia inanimals, including dogs and cats. It can be used, usually with valium, priorto surgery, a dental cleaning and sometimes as a form of restraint forprocedures such as an imaging scan. It's not the only drug that can be usedin this way, but it's one of the most common. The only explanation so far given as to just what's wrong with the recalledketamine came in a press release issued by the FDA on Dec. 22, which said,"This recall is being conducted as a result of an increased trend in seriousadverse events associated with this product, including lack of effect,prolonged effect, and death." Timeline of a recall Because pets are anesthetized more often than humans -- for example, nearlyall dogs and cats are spayed and neutered at a young age -- the potentialnumber of affected animals is huge. You'd expect, then, that veterinarians,the people who are buying and administering these drugs, would have been thefirst to learn that they were being recalled. You'd be wrong. Although it was the nation's largest manufacturer of generic animal drugs,almost no one in the veterinarian community had heard of Teva Animal Healthuntil the FDA shut it down on July 31, citing adulterated drugs and multipleviolations of good manufacturing practices at its St. Joseph, Mo., facility. If you were a veterinarian or a member of the public, there was no furthernews about Teva until Dec. 22, when the FDA announced the company wasrecalling its injectable ketamine hydrochloride following the questionabledeaths of five cats undergoing anesthesia with the drug. It was obvious something else had occurred between the summer shutdown andTeva's announcement, however, because the FDA's recall notice referenced anearlier "distributor-level recall." But there was no copy of that recallnotice on the FDA website, it didn't appear to have been published anywhere,nor could I locate a single veterinarian who had seen a copy. If they had seen it, what happened a week later would have come as less of asurprise. On Dec. 29, Teva announced that the recall was extending toketamine manufactured by Teva but sold under the brand names of some of thebiggest players in the veterinary -- and human -- pharmaceutical world:Ketaset (Fort Dodge/Pfizer), KetaVed (VEDCO), KetaThesia (Butler), VetaKet(LLOYD Laboratories), Ketaject (Phoenix), Keta-Sthetic (RVX),and AmTechGroup, Inc. The information flow stops here Veterinarians, along with their patients' owners, suddenly realized theywere the last link in a mostly-broken chain of information emerging -- or,more correctly, trickling out -- from Teva, the companies for which it wasmanufacturing drugs, their distributors and the FDA. There are many unanswered questions. For example, how far back in time didthe recall extend? Dates listed on the site of the American VeterinaryMedical Association suggest that the recalled ketamine has been distributedto veterinarians as early as 2006, a timeline confirmed by Denise Bradley,senior director of corporate communications for Teva. Furthermore, why did it take so long to notify veterinarians about theketamine recall, and why have they still not been notified about thebutorphanol recall, which includes the brands EQUANOL (VEDCO), ButorJect(Phoenix) and TorphaJect (Butler)? I contacted the FDA's Center for Veterinary Medicine about the earlier"distributor-level recall," and Laura Alvey, the agency's communicationsstaff deputy director, e-mailed me a copy of the notice sent by Teva to itsdistributors. That letter, signed by Joseph DelGobbo of Teva's quality control departmentand dated Sept. 4, stated that the distributors were under no obligation tonotify their customers -- veterinarians -- about the recall. "If you want torequest return of product from your customers," it read, "that is acceptablealthough not required." The letter also included this statement: "This recall is being conductedvoluntarily and with the knowledge of the Food and Drug Administration."(Note: All recalls are voluntary, as the FDA does not have mandatory recallauthority.) That Sept. 4 distributor-only recall included all the brand name ketamineproducts not referenced until the second, "expanded" recall on Dec. 29, aswell as the butorphanol recall that has still not been publicly announced. "It's been extremely frustrating to veterinarians," said Jennifer Fiala, whohas been investigating the recall for the Veterinary Information Network, orVIN, an online community and information database for veterinarians andveterinary students. "They're worried that the drug on their shelves isgoing to create an adverse event in the animals they treat." That frustration is compounded by the fact that veterinarians have no way ofknowing whether or not the drugs in their clinics were manufactured by Teva. Alvey provided me with the federal government's labeling regulations fordrugs. They're difficult to decipher, but buried in the text is the factthat drugs made by Company A and sold under the label of Company B canlegally bear the label "Manufactured for Company B." The drug label does nothave to include where, or by what company, a drug was actually produced. Fiala finds that appalling. "Wouldn't it have been nice for a vet to be ableto look at the label on a vial of Ketaset and see it was manufactured byTeva?" she said. "I can look at the label on my shirt and it will tell me itwas made in China, but it can't say 'made in St. Joseph, Mo.' on a drugyou're supposed to ingest or administer?" 2007 pet food recall redux? This complaint probably sounds familiar to anyone who remembers the 2007 petfood recall, when questions about who made your pet's food, and whether anyof its ingredients came from China, were impossible to determine fromreading the label. The 2007 pet food recall was also marked by enormous problems in obtaininginformation from the FDA. Many journalists and bloggers, including me,regularly reported recalls that the FDA did not announce until days or evenweeks later -- a scenario that's playing out all over again today. As of this writing, the ketamine recall information on the FDA's veterinaryrecall information page is limited to a link to the Dec. 21 notice. The ketamine recall has not been mentioned on the FDA's much-hyped pethealth alert widget, which has so far mostly been used to issue mundane petholiday safety warnings. There is also no sign of the Dec. 29 notice expanding the recall, althoughit was reported by Jennifer Fiala on VIN as well as on Pet Connection. Nor did the FDA update its site with a list of recalled brands and their lotnumbers, which can be found instead on VIN and on the site of the AmericanVeterinary Medical Association. Broken faith Dr. Paul Pion, a veterinary cardiologist in Davis, and co-founder andpresident of VIN, deplores the faltering, sometimes dammed-up, flow ofinformation from both the drug companies and the FDA. "Once it becomes clear there is a problem, all concern should turn togetting the information to veterinarians so they can do the right thing fortheir patients," Pion said. "Everyone who has the information, whether theybelieve it's their job or not, should share it. "Damn the lawyers, corporate protocol, quarterly sales goals or fear ofbeing blamed. Because the truth will ultimately be known, and any attempt todelay or sugarcoat the information serves only to dissipate confidence inthe entire system. And any individual or company who has reliableinformation and doesn't share it should be held personally and corporatelyresponsible for any adverse reactions that occur after that." That's a battle cry pet owners can rally behind, including the owner of adog named Rogue, who lives in Washington state and asked that her name bewithheld so as not to cause problems with her veterinarian, who is stillcaring for her dog. "Rogue broke his tooth, and it became infected," she said. "In mid-December,I took him to the best veterinarian in our area, a specialist, and shescheduled him for surgery to remove the tooth." Neither Rogue's owner nor the veterinarian cut any corners. At 10 years old,Rogue, a chow-chow, is considered a canine senior citizen, so he had what'sknown as a "geriatric panel," blood tests that screen for common old-ageproblems that might make anesthesia more risky for him than a younger dog. "The vet listened to his heart with a stethoscope when she examined himbefore the surgery," his owner said. "He was fine. Everything came backnormal." But shortly after the veterinarian injected Rogue with a combination ofketamine and valium, his heartbeat became abnormal. She had to immediatelyabort the procedure and wake him up to protect his life. Rogue was referred to a heart specialist, who diagnosed him with a seriouscondition known as a second-degree heart block. There's no way to know ifthe anesthesia caused the heart condition, or if it was the result of somepreviously undiagnosed problem. But when his owner heard about the ketaminerecall on Dec. 22, she checked with her vet right away. The veterinarian assured her that she hadn't used Teva's ketamine on Rogue,but Fort Dodge's Ketaset instead. Unfortunately, a few days later, Rogue'sowner learned that brand, too, was being recalled. She followed up with afax to her veterinarian asking about the expanded recall and what risk itmight pose to her dog, but so far has had no response. This void of information, from the highest corporate levels of Big Pharma,to the halls of government, right down to the plight of a sick dog and hisworried owner, does as much damage to public health as tainted food anddrugs. It does it by destroying trust. People lose faith in their doctors, petowners lose faith in their veterinarians, and veterinarians and doctors aswell as average citizens lose faith in agencies like the FDA, ostensiblytasked with protecting both human and animal health. "The domino effect applies," observed Fiala. "Everybody falls." © 2010 Hearst Communications Inc. To report corrections and clarifications, contact Reader Editor Brent Jones.For publication consideration in the newspaper, send comments toletters@usatoday.com. Include name, phone number, city and state forverification. FDA: http://content.usatoday.com/topics/topic/Federal%20Drug%20Administration
This is distibuted for nonprofit research and educational purposes only.
http://www4.law.cornell.edu/uscode/17/107.html

Friday, January 1, 2010

Expanded ketamine recall leaves veterinarians with unanswered questions

The reported death of five cats prompted Teva Animal Health to widen its
recall to include all vials of ketamine hydrochloride injection last week,
yet the company¹s technical services department insists that the action was
caused merely by ³increased medical events that were kind of unfounded.²

That statement, offered by a Teva technical services representative who did
not give her name, has confused some veterinarians. On Dec. 22, the U.S.
Food and Drug Administration (FDA) issued a recall alert, instructing
practitioners to stop using all 27 lots of Teva¹s ketamine hydrochloride
injection, USP CIII 100 mg/ml in 10 ml vials due to ³serious adverse
events.²

The expiration dates of the lots range from September 2009 to February 2012,
the FDA says. Additionally, the American Veterinary Medical Association
(AVMA) warns practitioners not to rely on the Teva brand name to determine
whether their ketamine falls under the recall. Rather, the following signs
offer a better indication:

* If the lot number is six numeric digits, the product is not part of
the recall.
* If the lot number is seven numeric digits, the product should be
returned.
* If the lot number starts with 5401, regardless of the number of digits
or the presence of
letters in the lot code, the product should be returned.

According to the FDA, reported problems with Teva¹s ketamine include lack of
effect, prolonged effect and death.


In response, practitioners have contacted the VIN News Service (VNS) looking
for insight into the recall, which originated last summer and, at the time,
took effect only at the wholesale level.

Troubles within Teva Animal Health surfaced in late July, when the FDA shut
down the company via a permanent injunction and filed a lawsuit, alleging
that regulatory inspectors had uncovered adulterated animal drugs at Teva¹s
main facilities in St. Joseph, Mo. The generics manufacturer agreed to cease
production of its drugs and its DVM Pharmaceuticals line of products
following a much-publicized crackdown by the FDA on the company¹s quality
control practices.


At the time, Michael Chappell, the FDA¹s acting associate commissioner for
regulatory affairs, stated: ³The FDA will not tolerate the manufacture and
distribution of adulterated animal drugs. Veterinarians and pet owners can
be assured that the FDA will investigate and take regulatory actions against
companies that produce animal drugs under conditions and controls that are
inadequate to assure their safety and quality.²

But Laura Alvey, deputy director of communications with the FDA¹s Center for
Veterinary Medicine (CVM), notes in a recent interview with the VNS that,
³FDA¹s evaluation was that use or exposure to these products was not likely
to cause adverse health consequences.²

To some, that assessment now appears flawed, considering veterinarians have
been ordered to stop using Teva ketamine and to return it to their
distributors because of the reported feline deaths.

Rumors also have surfaced that the recall affects ketamine manufactured by
Teva but sold under private labels. Dr. Sue Kelly, a VIN member and
acupuncturist in West Halifax, Vt., says that a Butler Animal Health
representative warned that her bottle of Butler-labeled ketamine was
included in the recall.

³Nowhere on the label does it say where it was manufactured,² Kelly says of
her vial, now boxed and ready for shipment to Butler. ³So I called Butler
last week, and they told me that it is under the recall and to send it back
for a refund. If, in fact, there is product out there that¹s not labeled as
Teva but is made by them and it¹s hard for us to trace, that¹s truly
alarming.²

While CVM representatives did not immediately respond to a VNS request for
clarification, AVMA notes in a Web alert that, "Teva Animal Health also
manufactures ketamine products for other companies."


Kay Knox, manager of the Butler¹s regulatory affairs, refutes the suggestion
that the recall extends beyond Teva's label and says that she¹s in the
process of sending 14,000 letters to veterinary customers with more of an
explanation.

³What I¹m telling (veterinarians) right now is that it has to be
manufactured by Teva within the dates on the recall notice,² Knox says.
³Maybe if my phone stopped ringing I could get these letters out to answer
these questions.²

Knox stated that the phone calls she alludes to have not come from
veterinarians.

According to CVM spokeswoman Alvey, the events that led up to the ketamine
recall expansion began on Nov. 19, when Teva Animal Heath received a report
of two cat deaths linked to use of the drug four days earlier. On Dec. 4,
the company received three more reports that cats had died following the use
of ketamine; two on Oct. 2 and one on Dec. 2. All of the cats received Teva
ketamine from the same lot.

Teva Animal Health forwarded reports of those incidents to the FDA on Dec.
7, and the agency received them on Dec. 11.

³The company is not out of compliance with ADE (adverse drug experience)
reporting requirements,² writes Alvey in an e-mail to VNS.

She went on express some uncertainty that the adverse reactions were
indisputably related to Teva¹s ketamine or problems with the drug, by
explaining that the anesthetic is typically used in combination with other
agents. She also reinforced the fact that all anesthetic drugs ³have some
inherent risk with the use of them.²

³It is not uncommon to receive reports of one to five deaths per year that
may or may not be related to the product,² she writes. ³Determining the
causality is difficult because of many potentially contributing factors,
including other anesthetic agents used, product used during surgical
procedures, etc.²

That¹s not news to veterinarians, considering most administer anesthetic
drugs to manage pain in patients on a regular basis.

But Dr. Meghan Richey, a VIN consultant and boarded anesthesiologist who
practices in Oklahoma and regularly uses Fort Dodge¹s Ketaset, notes that
most pharmaceutical preparations of ketamine are racemic mixtures. Because
of this, she wonders if the mixture of sterioisomers in Teva¹s ketamine
might be off kilter, explaining that the mixture is not always 50/50 in some
generic brands due to improper screening.

Such chemical differences, Richey says, can work to lessen the anesthetic
agent¹s potency or, if there is more of the active S(+) isomer present,
cause an exaggerated effect. Richey is careful to note that when it comes to
the recall of Teva¹s ketamine, she¹s merely guessing. But a difference in
the relative concentrations of the isomers could account for unusual
reactions to the drug or other medical events.

³I don¹t have a lot to go on,² she says. ³Given the information I have, I am
speculating at best.²

When posed with the idea that the drug¹s concentration might be off, the
Teva technical services representative contacted by VNS insisted: ³It¹s
nothing with the drug. It¹s not super-potent.²

Dr. Kristin Fuhrman, of Teva, did not return VNS phone calls seeking a more
detailed explanation. Teva spokeswoman Denise Bradley could not be reached
for comment.

Veterinarians with questions about the recall can contact Teva Animal Health
at (800) 759-3664. Business hours are between 8 a.m. and 5 p.m. CST,
weekdays.

Wednesday, October 21, 2009

Wysong Pet Food Pulls Products Due To Mold

A third pet food company in as many weeks has pulled some of its products
off the market.

Wysong Pet Food confirmed that it recalled five batches of Canine Diets
Maintenance and Senior dry dog food -- manufactured in June and July 2009 --
because the products contain mold.

"Penicillium and fusarium mold species have been identified," Lucas Wysong,
the company's vice-president, told ConsumerAffairs.com. "All mycotoxin tests
conducted thus far are negative with regard to the recalled products."

"That we released some product that was not of the highest quality and may
have caused any animals harm makes us frankly ashamed and heartsick," he
added.

Specifically, the Michigan-based pet food maker recalled the following
batches of dry dog food:

€ Wysong Maintenance: lot #: 090617

€ Wysong Maintenance: lot #: 090624

€ Wysong Maintenance: lot #: 090706

€ Wysong Maintenance: lot #: 090720

€ Wysong Senior: lot #: 090623

ConsumerAffairs.com talked to a pet owner in Hawaii who says her Doberman
Pinscher recently died -- and her eight other dogs became sick -- after
eating Wysong's moldy food.

Lucas Wysong said his family's company is working closely with that pet
owner. He called the case "exceptional" and said his company has received
only two other minor complaints -- reports of diarrhea -- linked to the
recalled food.

Wysong told us his company discovered the problem in late September after it
investigated customer complaints' of possible mold contamination in the
food.

In a prepared statement, Wysong said "At first report of potential mold in
our products, Wysong launched an internal investigation. Batch records were
re-examined, numerous bags of product opened and scrutinized, product
samples were acquired from customers, and testing in-house and out-of-house
conducted."

That investigation, the company said, revealed the problem with the food
stemmed from the "unusually high heat and humidity" on the days the products
were made in June and July. The company also blamed the higher moisture
issues on a "malfunctioning moisture checking device."

Wysong said his company notified its distributors about the problem on
September 29, 2009.

"Once Wysong ascertained that there was mold presence and the potential for
mold (based on moisture tests) in certain batches we alerted our
distributors, who were the primary recipients of these batches of product,"
he said. "Distributors were instructed to dispose of the product, as well as
pull product from stores that had already received the product."

The company also said it contacted stores that received the recalled product
and asked them to remove the food from store shelves. In addition, the
company destroyed any "problematic" batches that remained in-house.

Wysong also told us that his company notified the Food and Drug
Administration (FDA)about the mold problem. The FDA's new Reportable Food
Registry requires U.S. companies to file a report when there is a
"reasonable probability" that their food will cause serious health
consequences to people or animals.

Wysong also posted a recall notice on its Web site, but that warning is
buried under the dry dog food section.


When asked why his company didn't immediately notify pet owners about the
mold problem, Wysong said "The vast majority of the recalled product was
sent to our distributors and retailers. We have therefore focused our
efforts on alerting distributors and stores and asked them to dispose of the
product."

"In other words, we are focusing on the supply chain because the customers
at the retail/store level are not identifiable," he said.

Wysong admitted that posting a notice on the company's Web site is not the
most effective way to reach customers who may have the recalled products.

"The actual recipients of the product -- distributors and retailers -- have
already been alerted, and those that buy our product in stores are likely
not Wysong.net site visitors," he said. "The notice on the site therefore
serves as an alert to those who did not receive these products."

"We keep records of the distributors and stores that were shipped this
product," he added. "Our best chance at notifying customers is through these
mediums."

Pet owners who have any of the recalled food should immediately stop feeding
it to their dogs, Wysong said.

"She did not deserve to die that way"

That warning, however, came too late for Julie P. of Hawaii. She says her
healthy Doberman Pinscher, Scarlet, died on September 26, 2009, after eating
some of Wysong's moldy food.

"Losing Scarlet was just horrible and totally needless," Julie told us. "She
died a very painful and agonizing death on the morning of her fifth birthday
after suffering all night long. She had gone completely toxic."

But Julie's nightmare didn't end with Scarlet's death. Her other eight
Dobermans also became seriously ill after eating Wysong's moldy food.

"They're lethargic and continued to get more and more down as time went by,"
says Julie, who switched her dogs to Wysong in August. "They have very red
eyes with yellow gunk that they have had the whole time I was feeding
Wysong. That has now finally gone away because I took them off the food
after Scarlet died," she said.

"They also had severe diarrhea the whole time, too. At first I thought it
was from the changing of their food, but it got worse with some bloody
stools and did not go away until again I stopped feeding them Wysong."

One of Julie's dogs, a male named Doug, also developed a sore on his leg
that would not heal and had "dry flaky skin with red bumps on his neck."

"Several of my other dogs, including my Daddy, Ruby, and Maybelle all have a
bad rash on their groin areas that I also could not get to go away for the
last two months," Julie says. "They have had gaseous upset stomachs many
times in the last two months. They have been throwing up, and at times, Doug
refused to even get near his feeding dish."

Julie says she didn't make a connection between Wysong's food and her dogs'
death and illnesses until she opened a new bag on October 4, 2009.

"When I opened that bag, I noticed a moldy look to the kibble -- a look I
had seen on several previous bags in the two months I feed it to my dogs. I
did not notice any smell, but I think my dog Doug did."

Julie contacted the company that same day. "I was afraid to feed them what
looked to me like moldy food," she says. "And I started putting all these
symptoms together as being from the food."

"I'm not sure how I can prove that all of these symptoms were from eating
the bad dog food," she adds. "But now that I've stopped feeding the food to
them, they are all getting better, which seems to prove that it was."

Julie says Wysong should give her some compensation -- at least enough to
cover her vet bills -- but no amount of money can ever replace Scarlet.

"She did not deserve to die that way," Julie says. "She was still a young
and vibrant dog and very, very special to us. She could have gone on to live
another ten years...it's hard to put a price tag on that. What would you pay
to have your loved one with you for all those days?"

Lucas Wysong told us his company is "immensely sorry" for any worry or
inconvenience this issue has caused its customers.

In Julie's case, Wysong said his company is in "direct communication" with
her regarding the death of Scarlet and the illnesses of her other dogs.

"We have requested specific tests be conducted in an attempt to definitively
determined the cause of death/sickness," he said, adding the company has not
received any other reports of serious adverse reactions linked to the
recalled food.

The company, he added, has also taken steps to ensure a mold problem like
this doesn't surface again.

"We are in the midst of scrutinizing each and every step of our quality
assurance processes," he said. "All products going back for months are being
tested for moisture and mold, thus eliminating the possibility of further
problematic product (if any exists) being released.

"We vow to all interested parties to do everything we can to ensure that
this never happens again."

Julie, however, isn't taking any more chances with Wysong's food.

"Like a lot of people I am going to be making my own food for my dogs. But
with this many to feed, that's a challenge. It can be hard to get all the
vitamins in there, so I would like to supplement with a small amount of
kibble."

Meanwhile, pet owners who have any of Wysong's recalled food -- or questions
about the recall -- can e-mail the company at Wysong@Wysong.net


Third in a series

Wysong is the third pet food maker in recent weeks to quietly pull some of
its products off the market.

Earlier this month, Diamond Pet Foods removed some of its Premium Edge
Finicky Adult and Hairball cat food off the market because of deficiencies
in the thiamine levels.

Diamond's action came just days after Nutro Products quietly pulled from the
market three types of its puppy food because of a production error.


The company said it voluntarily withdrew the puppy food after it had
discovered pieces of melted plastic in the "production line of select
varieties of NUTRO dry dog and cat food products."


Report Your Experience

If you've had a bad experience -- or a good one -- with a consumer product
or service, we'd like to hear about it. All complaints are reviewed by class
action attorneys and are considered for publication on our site. Knowledge
is power! Help spread the word. File your consumer report now.


More Links at web site:
Links:
€ NUTRO Updates Information on Puppy Food Recall
€ NUTRO Pulls Some Puppy Food from Shelves
€ FDA Agrees to Reconsider Request for NUTRO Records
€ Tests Find 'Sky High' Zinc Levels in NUTRO Cat Food
€ Cat Owners Bristle at NUTRO Denials
€ Consumers React to NUTRO Recalls; Zinc, Copper Levels Cited
€ NUTRO Recalls Dry Cat Food Sold in 11 Countries
€ Consumer Site Appeals FDA's Refusal to Release NUTRO Records
€ Feds Deny NUTRO Investigation; Witnesses Say Otherwise
€ NUTRO Bites Back; Denies Probe of Pet Deaths, Illnesses
€ FDA Confirms Probe of NUTRO Pet Food Deaths, Illnesses
€ Lawsuits On the Trail of Nutro, Canidae Pet Foods
€ Mars Extends Pet Food Recall; More Salmonella Found
€ Mars Recalls Cat Food Sold at Wal-Mart due to Salmonella
€ Mars Recalls More Pet Food; Possible Salmonella Contamination
€ Mars Petcare Recalls Some Pedigree Dog Food
€ Expert Finds Unexplained Pet Deaths 'Not Consistent'
€ Illness, Death Dog Nutro Pet Food
€ String of Illnesses Afflicts NUTRO-Fed Pets
---
€ Complaints about NUTRO
€ Consumer Complaints about Greenies
---
€ Nutro Recalls Dry Cat Food Products
€ More about Pet Food Recalls
Full story:http://www.consumeraffairs.com/news04/2009/10/wysong_pet_food.html

Thursday, August 6, 2009

California Firm Recalls Ground Beef Products Due to Possible Salmonella Contamination

Recall Release CLASS I RECALL
FSIS-RC-041-2009 HEALTH RISK: HIGH

Congressional and Public Affairs
(202) 720-9113
Brian K. Mabry

WASHINGTON, August 6, 2009 - Beef Packers, Inc., a Fresno, Calif., establishment, is recalling approximately 825,769 pounds of ground beef products that may be linked to an outbreak of salmonellosis, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall include:
60 pound cases of "GRD Beef Sirl Fine 90/10." Each case bears the identifying case code W69012 with Use/Freeze by dates of 06/23/09, 06/26/09, 06/28/09, 06/29/09, 06/30/09, 07/03/09, 07/05/09, 07/06/09, 07/07/09, 07/10/09 and 07/11/09.
60 pound cases of "Grnd Bf Fine Sir 90/10 10/60 H". Each case bears the identifying case code W69064 with Use/Freeze by dates of 06/26/09, 07/03/09, 07/06/09, 07/07/09 and 07/14/09.
60 pound cases of "Grnd Beef 90/10 Fine 60." Each case bears the identifying case code W69063 with Use/Freeze by dates of 06/23/09, 06/26/09, 06/30/09, 07/03/09, 07/07/09, 07/10/09 and 07/11/09.
80 pound cases of "Grnd Beef Fine 91/09 10#/80." Each case bears the identifying case code W69108 with Use/Freeze by dates of 06/30/09, 07/06/09, 07/08/09 and 07/13/09 .
60 pound cases of "Grnd Beef Fine 93/07 10/60." Each case bears the identifying case code W69363 with Use/Freeze by dates of 06/23/09, 06/26/09, 06/28/09, 06/29/09, 06/30/09, 07/03/09, 07/07/09, 07/10/09 and 07/11/09.
60 pound cases of "Grnd Beef Fine 93/07 10#/60 H." Each case bears the identifying case code W69360 with Use/Freeze by date of 06/26/09, 07/03/09, 07/06/09, 07/10/09 and 07/14/09.
40 pound cases of "GRD BEEF FINE 96/04-10#/40." Each case bears the identifying case code W69602 with Use/Freeze by dates of 06/23/09, 06/30/09, 07/03/09, 07/07/09, 07/10/09 and 07/11/09. The rest of the article:
http://www.fsis.usda.gov/News_&_Events/Recall_041_2009_Release/index.asp