FDA recalls

[GinaMarie]

I get all the FDA recalls on email. I thought I could also post them on here so you can see the most recent recalls. Here is the site with the past recalls in the past 60 days.

http://www.fda.gov/opacom/7alerts.html


If you all want me to keep posting them just let me know. Maybe the moderators can keep it as a sticky post. I also get recalls that ARENT dog food like some on the above link have olives and other things I can post also.
GM

[GinaMarie]

T.W. Enterprises Issues Nationwide Recall of Dog Chews Due to Salmonella Contamination
Contact:
T.W. Enterprises
(360) 366-0408

FOR IMMEDIATE RELEASE -- Ferndale, WA -- April 16, 2007 -- T.W. Enterprises of Ferndale, WA today alerted consumers that it is recalling certain dog chews it markets because they may be contaminated with Salmonella. Samples tested by FDA of the product indicate that the dog chew products manufactured by T.W. Enterprises may be contaminated. People handling these treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the chews or any surfaces exposed to these products.

Salmonella can potentially be transferred to people handling these pet treats, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Well animals can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The following is a list of the recalled products (Product Name/ A.B. Dog Chew - Size / UPC):

A.B. Small Chew, 3 - 4 inch / 833234001105
A. B. Puppy Chew, 4 - 6 inch / 83323401112
A.B. Dog Chew Medium, 6 inch / 833234001051
A.B. Dog Chew Large, 10 inch / 833234001068
A. B. Dog Chew XL, 13 inch / 833234001075
A. B. Dog Chew Mega, 16 inch / 833234001082
A. B. Dog Chew Jumbo, 26 inch / 833234001099
T.W. Enterprises Inc. manufactured these dog chews and distributed them throughout the United States under its name. The affected products were distributed before March 22, 2007 to retail locations and are non-coded, i.e. they have no batch code or other identifying marks. T.W. Enterprises has made contact with all of its consignees and has been informed the affected product has been pulled from store shelves.

T.W. Enterprises has informed FDA of its action and is fully cooperating with the agency. The firm, FDA and other authorities are actively investigating this matter to determine the source of this problem, and will take any additional steps necessary to protect the public health. No reports of illness to date in connection with this problem.

Consumers who have the non-coded pet chews should not feed them to their pets, but should dispose of them in a safe manner (e.g., in a securely covered trash receptacle). Anyone who is experiencing the symptoms of Salmonella infection after having handled one of these pet products should seek medical attention, and report their use of the product and illness to the nearest FDA office.

People should thoroughly wash their hands after handling any pet treat – especially those made from animal protein such as meat -- to help prevent infection. People may risk bacterial infection not only by handling the chews, but by contact with pets or surfaces exposed to the chews, so it is important that they thoroughly wash their hands with hot water and soap.

Since elderly people, young children, and people with weakened immune systems are particularly at risk from exposure they should avoid handling these products.

Consumers with questions may contact T.W. Enterprises at 1-360-366-0408.

####



FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Natural Balance Pet Foods, Inc. Issues A Voluntary Nationwide Recall on Specific Venison Dog and Cat Food Products Contact:
Consumer Inquiries:
(800) 829-4493
Media Inquiries:
Daniel Bernstein
310-275-0777

FOR IMMEDIATE RELEASE -- Pacoima, CA -- April 17, 2007 -- Natural Balance, Pacoima, CA, is issuing a voluntary nationwide recall for all of its Venison dog products and the dry Venison cat food only, regardless of date codes. The recalled products include Venison and Brown Rice canned and bagged dog foods, Venison and Brown Rice dog treats, and Venison and Green Pea dry cat food. Recent laboratory results show that the products contain melamine. We believe the source of the melamine is a rice protein concentrate. Natural Balance has confirmed this morning that some production batches of these products may contain melamine.

The recall was prompted by consumer complaints received by Natural Balance involving a small number of cats and dogs that developed kidney failure after eating the affected product.

Dogs or cats who have consumed the suspect food and show signs of kidney failure (such as loss of appetite, lethargy and vomiting) should be seen by a veterinarian. We recommend our customers immediately stop feeding our recalled venison products regardless of date code and return unused product to their retailer for a full refund.

The products are packaged in bags, cans and zip lock treat bags and sold in pet specialty stores and PetCo nationally.

No other Natural Balance products are involved in this voluntary recall as none of our other formulas include the rice protein concentrate.

Although the problems seem to be focused on a particular production period of the venison products, over the last four days we have notified our distributors and retailers by phone and e-mail to immediately stop selling and return all recalled Venison dog foods and treats and the Venison dry cat food. Venison canned cat food is not involved.

The source of the melamine appears to be a rice protein concentrate, which was recently added to the dry venison formulas. Natural Balance does not use wheat gluten, which was associated with the previous melamine contamination.

None of Natural Balance's other dry formulas, none of our other canned or roll products and none of our other treats are involved with this voluntary recall.

We continue to work closely with the FDA in their ongoing investigation.

Consumers with questions may contact the company at 1-800-829-4493 or visit the website at www.naturalbalance.net.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations
U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals today seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA's Web site.

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.

Medical devices manufactured by Shelhigh include:

Shelhigh Pericardial Patch
Shelhigh No-React Pericardial Patch
Shelhigh No-React PneumoPledgets
Shelhigh No-React VascuPatch
Shelhigh No-React Tissue Repair Patch/UroPatch
Shelhigh Pulmonic Valve Conduit No-React Treated
Shelhigh No-React Dura Shield
Shelhigh BioRing (annuloplasty ring)
Shelhigh No-React EnCuff Patch
Shelhigh No-React Stentless Valve Conduit
Shelhigh Internal Mammary Artery
Shelhigh Gold perforated patches
Shelhigh Pre Curved Aortic Patch (Open)
Shelhigh NR2000 SemiStented aortic tricuspid valve
Shelhigh BioConduit stentless valve
Shelhigh NR900A tricuspid valve
Shelhigh MitroFast Mitral Valve Repair System
Shelhigh BioMitral tricuspid valve
Shelhigh Injectable Pulmonic Valve System
####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Jen-On Herbal Science International, Inc. Issues A Voluntary Nationwide Recall of H S Joy of Love, a Product Marketed as a Dietary Supplement Contact:
Dr. William Chang
(626) 333-9998

FOR IMMEDIATE RELEASE -- City of Industry, CA -- April 17, 2007- Jen-On Herbal Science International, Inc. 205 Russell St., City of Industry, CA 91744, announced today that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name H S Joy of Love. Jen-On Herbal Science International, Inc. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of H S Joy of Love samples found the product contains Piperadino Vardenafil, an analog of Vardenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Piperadino Vardenafil is close in structure to Vardenafil and is expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

H S Joy of Love is sold nationwide. The H S Joy of Love product is sold as a 12-capsule blister pack packaged in a retail box.

Consumers who have H S Joy of Love in their possession should stop using it immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Jen-On Herbal Science International, Inc. for a full purchase price refund by calling (626) 333-9998 for instructions on the return and refund process.

No illnesses have been reported to the company to date in connection with this product.

Jen-On Herbal Science International, Inc. apologizes for any inconvenience and expresses its concerns for the health of consumers by conducting a voluntary recall action. Jen-On Herbal Science International, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

####



FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- State Press Release



This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Butler County DairyContact:
Chris L. Ryder
(717) 503-0035 (cell)

FOR IMMEDIATE RELEASE -- Harrisburg, PA -- April 13, 2007 -- Consumers who have purchased raw milk from Fisher's Dairy, Butler County, any time after April 9, 2007, should discard it immediately due to the risk of Listeria monocytogenes contamination, Agriculture Secretary Dennis Wolff said today.

"During routine inspection, a preliminary test showed the presence of Listeria bacteria in some of the raw milk samples taken from Fisher's Dairy," said Wolff. "If consumers have raw milk from this farm, they should discard it immediately."

There have been no illnesses reported because of the potential contamination, but if individuals who consumed the raw milk become ill, they are advised to consult their physician.

Raw milk is milk that has not been pasteurized or homogenized.

The Department of Agriculture has suspended sales of raw milk at the dairy and is ensuring that corrective action is taken. Samples taken from the farm during routine testing on April 9 tested positive for Listeria on April 13.

Multiple laboratory samples must come back negative before sales can resume.

Symptoms of Listeriosis are fever, muscle aches, and sometimes gastrointestinal symptoms such as nausea or diarrhea. If infection spreads to the nervous system, symptoms such as headache, stiff neck, confusion, loss of balance or convulsions can occur.

Infected pregnant women may experience only a mild, flu-like illness, but infections during pregnancy can lead to miscarriage or stillbirth.

Symptoms of Listeriosis can appear in four days to three weeks.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[joy]

thank you gina. things have been very hectic here at our house lately and i had not kept up with the list. i just checked yours and so far my meanness is still doing ok even though he did eat several canned that was on the list. vet check him out, everything so i had put it out of my mind. boy i can't even stand up long enough to cook for hubby and myself so having to make dog food from scratch is out of the question.

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Wilbur-Ellis Voluntarily Recalls Rice Protein Concentrate
Contact:
Ann Barlow
415-438-9826; 925-200-6539
Deborah Brown
212-931-6113

FOR IMMEDIATE RELEASE -- San Francisco, CA -- April 18, 2007 -- Wilbur-Ellis Company is voluntarily recalling all lots of the rice protein concentrate the San Francisco company’s Feed Division has shipped to pet-food manufacturers because of a risk that rice protein concentrate may have been contaminated by melamine, an industrial chemical used to make plastics and fertilizers that can lead to illness or fatalities in animals if consumed.

Wilbur-Ellis noted that it obtained rice protein from a single source in China and shipped to a total of five U.S. pet-food manufacturers located in Utah, N.Y., Kansas and two in Missouri.

Last Sunday, April 15, Wilbur-Ellis notified the U.S. Food and Drug Administration that a single bag in a recent shipment of rice protein concentrate from its Chinese supplier, Binzhou Futian Biology Technology Co. Ltd., had tested positive for melamine. Unlike the other white-colored bags in that shipment, the bag in question was pink and had the word “melamine” stenciled upon it. Wilbur-Ellis separated that bag and quarantined the entire shipment for further testing and since that time, no further deliveries of rice protein concentrate have been made. Samples from the white bags tested negative for melamine. However, subsequent and potentially more sensitive tests by the FDA came back positive for melamine, leading Wilbur-Ellis to voluntarily issue the recall.

Wilbur-Ellis began importing rice protein concentrate from Binzhou Futian Biology Technology in July 2006. A total of 14 containers holding 336 metric tons of rice protein concentrate were sent from Futian to Wilbur-Ellis. Wilbur-Ellis has distributed 155 metric tons to date.

On Monday (April 16), a pet food distributor issued a voluntary recall of its pet food, believing the source of contamination to be rice protein concentrate supplied by Wilbur-Ellis. As an additional precaution, Wilbur-Ellis is urging all pet food manufacturers using rice protein concentrate supplied through Wilbur-Ellis to recall any pet food that may be on supermarket shelves.

Consumers with questions about the pet food they use should visit the FDA Web site at www.fda.gov.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Royal Canin USA Announces the Voluntary Nationwide Recall of its Dry Pet Food Products Containing Rice Protein Concentrate

Contact:
Erik Mueller
636-926-1089

FOR IMMEDIATE RELEASE -- St Charles, Missouri -- April 19, 2007 -- Royal Canin USA is announcing today that the company has determined there is a melamine derivative in the rice protein concentrate in some of its dry pet food products.

Although Royal Canin USA has no confirmed cases of illness in pets, we have decided to voluntarily remove all of our dry pet food products containing rice protein concentrate. We are taking this proactive stance to avoid any confusion for our customers about which Royal Canin USA products are safe and which products may be affected.

"We are as passionate about the health and happiness of our customers' pets as we are of our own, so we are committed to taking the steps necessary to ensure this never happens again," said Olivier Amice, President and CEO of Royal Canin USA.

As a precaution, Royal Canin USA is voluntarily recalling the following dry pet food products:

ROYAL CANIN VETERINARY DIET™ (available only in veterinary clinics)
Dry Dog Food

Canine Early Cardiac EC 22™
Canine Skin Support SS21™
Dry Cat Food

Feline Hypoallergenic HP23™
ROYAL CANIN SENSIBLE CHOICE® (available in pet specialty stores nationwide)

Dry Dog Food

Chicken Meal & Rice Formula Senior
Lamb Meal & Rice Formula Puppy
Lamb Meal & Rice Formula Adult
Lamb Meal & Rice Formula Senior
Rice & Catfish Meal Formula Adult
Based on today's announcement, pet owners should immediately stop feeding their pets the Royal Canin USA dry pet food products listed above. Pet owners should consult with a veterinarian if they are concerned about the health of their pet. No other Royal Canin diets are affected by this recall and CONTINUE TO BE safe for pets to eat.

Along with this announcement, Royal Canin USA will no longer use any Chinese suppliers for any of our vegetable proteins.

"On behalf of the entire Royal Canin family, our hearts go out to the pet owners and everyone in the pet community who have been affected by all of the recent recalls," said Dr. Denise Elliott, Director of Scientific Affairs for Royal Canin USA. "We are working very closely with the FDA to assist in its efforts to determine the cause of this most recent and disturbing development."

The safety and nutritional quality of our pet food is Royal Canin USA's top priority as we understand that the health of pets comes first. Pet owners who have questions about this recall and other Royal Canin USA products should call 1-800-592-6687 or visit our web site at www.royalcanin.us.

All Royal Canin USA products have a satisfaction guarantee and we will refund or replace the diets that have been recalled.

####



FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Blue Buffalo Company Announces Voluntary Recall of One Production Run of Spa Select Kitten Dry Food

Contact:
Consumer Inquiries:
1-800-919-2833
Media Inquiries:
David Petrie
1-203-762-9751

FOR IMMEDIATE RELEASE -- Wilton, Connecticut, April 19, 2007 -- The Blue Buffalo Company today announced a voluntary recall of one production run of its Spa Select Kitten dry food.

The recalled 3 lb. and 7 lb. bags of Spa Select Kitten dry food have the production code "BEST IF USED BY MAR 07 08 B" printed on the bag. Consumers should check this information on the bag, which is printed on the back panel below the seal.

The Company has taken this action because the rice protein concentrate used for this particular production run was obtained from Wilbur-Ellis, the same company who supplied this ingredient to Natural Balance. Test results received the evening of April 18th indicated that this rice protein concentrate tested positive for melamine. This was the only production run that used rice protein from Wilbur-Ellis.

Upon receiving the test results, the Company notified the FDA today and immediately began this recall process.

Of the 5,044 bags produced in this particular production run, the Company was able to prevent the majority from ever entering retail distribution. The Company is working closely with its retail partners and believes that most of the recalled product that had reached retail distribution has already been pulled off the shelf.

Consumers should immediately stop feeding Spa Select Kitten dry cat food with the above-listed date codes to their kittens and consult with a veterinarian if they have any health concerns with their pet.

No other cat or dog foods, canned or dry, made by the Company are affected by the recall.

Should consumers have a specific question, they can email the Company at info@bluebuff.com or call 1-800-919-2833, Monday through Friday, 9 a.m. to 5 p.m. EDT, to receive more information.

Bill Bishop, CEO and President of The Blue Buffalo Company, commented "As a family owned company whose reason for being is to provide cats and dogs with the highest quality natural foods, we are extremely upset by this recall and can't begin to apologize enough to our customers. From our perspective, it is unacceptable to produce even one bag of food with the potential to cause a pet to become ill, and we will further tighten our ingredient sourcing and quality assurance procedures as a result of this incident."

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



LiveSmart Weight Management Chicken and Brown Rice Recall
Contact:
SmartPak
1-800-326-0282

STATEMENT: On Friday, April 20, SmartPak initiated a voluntary recall of a single production run of the LiveSmart Weight Management Chicken and Brown Rice Dog Food.

The particular lot of food recalled included rice protein concentrate that was supplied by Wilbur-Ellis, the same company that supplied rice protein concentrate contaminated with Melamine to Natural Balance. This was the first time that our supplier purchased and used rice protein concentrate from Wilbur-Ellis. No previous lots were affected, nor do we use rice protein concentrate in any other formulas of LiveSmart dog or cat foods.

Thankfully, the product was just produced, and only a very limited amount of product had left our facility prior to the recall (less than 1200 pounds). We have notified every affected pet owner via both phone and email.

We have not had any reports of injury to any dogs. Dogs who have consumed the LiveSmart Weight Management food and show signs of kidney failure (such as loss of appetite, lethargy and vomiting) should be seen by a veterinarian.

We have temporarily suspended further distribution of the LiveSmart Weight Management Chicken and Brown Rice Dog Food. We will notify you when we have the product back in stock and will continue to update our website as more information becomes available.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

__________________________________________________ _



Thanks for subscribing to the FDA Recalls list.



To subscribe to or unsubscribe from this list, go to

https://list.nih.gov/archives/fda-recalls-l.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Chenango Valley Pet Foods Issues Voluntarily Nationwide Recall of Certain Pet Foods

Contact:
Dennis J. Bobita
(610) 821-0608

FOR IMMEDIATE RELEASE -- April 26, 2007 -- Chenango Valley Pet Foods is working with the U.S. Food and Drug Administration and voluntarily recalling pet foods manufactured with a certain shipment of rice protein concentrate. The company was informed by Wilbur-Ellis that the rice protein concentrate shipped to Chenango Valley Pet Foods may be contaminated with melamine, and instructed Chenango Valley Pet Foods to recall any pet foods manufactured with the rice protein concentrate. Melamine is an industrial chemical used to make plastics and fertilizers that may lead to illness or fatalities in animals if consumed.

The pet foods were sold to customers in Wisconsin, Massachusetts, and Pennsylvania, who further sold the products to their customers through catalog mail-orders or retail outlets.

Only the following dry pet foods are involved in the recall:

DOCTORS FOSTER & SMITH CHICKEN & BROWN RICE FORMULA ADULT LITE DOG FOOD, NET WT. 5 LBS., 12.5 LBS, and 25 LBS; Code dates: Best Used By Jan 24, 09; Best Used By Feb 8, 09; Best Used By Feb 26, 09; Best Used By April 10, 09; Best Used By April 17, 09;

DOCTORS FOSTER & SMITH CHICKEN & BROWN RICE FORMULA ADULT LITE CAT FOOD, NET WT. 3 LBS. and 7 LBS.; Code date: Best Used By March 13, 09;

LICK YOUR CHOPS LAMB MEAL, RICE & EGG CAT FOOD, 4 LBS. packages,
Code date: Best Used By April 29, 08;

Bulk CHICKEN & BROWN RICE FORMULA ADULT LITE DOG FOOD sold to one consignee (SmartPak) in a 2000 lbs. tote, Ship date: Feb 9, 2007.

No illnesses or injuries have been reported to date.

Pet owners who purchased the pet foods should immediately discontinue using the products and return them to the place of purchase for a full refund. Pet owners should consult with a veterinarian if they have any health concerns with their pet. Consumers with questions may contact the company at 1-610-821-0608.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

Diamond Pet Food Withdraws Products in Response to American Nutrition Inc. Pet Food Recall

Contact:
Diamond Pet Food Media Hotline
(888) 207-6208

FOR IMMEDIATE RELEASE -- Meta, MO -- April 26, 2007 -- Because of the canned pet food recall initiated today by American Nutrition Inc., Diamond Pet Foods has announced it is withdrawing a limited number of canned products manufactured by American Nutrition. This action is limited to three specific canned products: Diamond Lamb & Rice Formula for Dogs 13 oz. cans, Chicken Soup for the Pet Lover's Soul Kitten Formula 5.5 oz. cans, and Chicken Soup for the Pet Lover's Soul Puppy Formula 13 oz. cans.

Diamond Pet Foods is taking this voluntary action after learning the Food and Drug Administration (FDA) confirmed rice protein concentrate used by American Nutrition contained melamine, a substance not approved for use in food.

No other Diamond brand or Chicken Soup brand canned or dry pet food formulas are affected by the American Nutrition recall.

Diamond Pet Foods has not received any indication of quality or safety issues, including pet illness, with the three withdrawn products. However, because American Nutrition informed the company that these three specific products may include rice protein concentrate, Diamond Pet Foods felt this action was necessary for the protection of its customers and their pets.

It should be noted that the products being withdrawn were not formulated or labeled to contain rice protein concentrate. While the FDA is investigating this, current information indicates this error is a result of a manufacturing deviation by American Nutrition.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Blue Buffalo Recalls Can and Biscuit Products Due To Tampering By American Nutrition Inc.
Contact:
Consumer Inquiries:
1-800-919-2833
Media Inquiries:
David Petrie
1-203-762-9751

FOR IMMEDIATE RELEASE -- Wilton, Connecticut, April 26, 2007- We at the Blue Buffalo Company have just learned that American Nutrition Inc. (ANI), the manufacturer of all our cans and biscuits, has been adding rice protein concentrate to our can formulas without our knowledge and without our approval. This is product tampering, and it apparently has been going on for some time. The can formulas that we developed, and trusted them to produce, never contained any rice protein concentrate. It appears that only an FDA investigation of ANI's rice protein concentrate supplies forced them to reveal this product tampering to us.

While this activity by ANI is in itself unlawful, the situation is further clouded by the fact that ANI has been receiving rice protein concentrate from Wilber-Ellis, some of which the FDA has determined to be contaminated with melamine.

So while no BLUE or Spa Select canned product has tested positive for the presence of melamine, and there has been no reported illness due to any of our canned products, we simply cannot be sure of what ANI has been including in our formulas. For this reason, we have decided to remove all of our canned and biscuit products from retail distribution. While this may seem to many to be a major over-reaction, as other ANI customers will probably only recall the products that tested positive for melamine, we see this as a matter of integrity.

We founded Blue Buffalo on the principle of providing dogs and cats with the highest quality and most nutritious food, and we will not sell any product that doesn't meet this standard. And under these circumstances, we cannot say that any products manufactured by ANI measure up.

The obvious question is "how could Blue Buffalo not know that ANI was putting rice protein concentrate into our canned food?" The answer is we trusted them. In business and in life, we all trust our partners to deal with us honestly. When we buy produce from our local grocery store, we are trusting growers, shippers and a series of handlers to have delivered a product that is safe and nutritious for our family. If any one of these parties betrays our trust, contaminated products can make their way to our dinner table.

And while we test for known toxins and contaminants, we don't test for protein sources, like rice protein concentrate, especially when we did not formulate our products to contain them.

In the end, this all comes down to an issue of integrity, and ANI has not been honest with us and with the pet parents who buy our products. We will not put any product made by ANI on the shelf, and are temporarily withdrawing an important part of our business in order to be true to our pet parents.

We have already started the process of identifying a can and biscuit manufacturer with whom we can build a partnership based on trust. Once we have accomplished this, BLUE and Spa Select cans and BLUE Health Bars will be reintroduced with the high quality and superior nutrition that our brand stands for and that dogs and cats deserve.

We have informed our retail partners and the FDA about this action and will be cooperating with them to complete this recall quickly. The specific product involved includes all "BLUE" brand can dog foods, all "Spa Select" brand can cat foods and all "BLUE Health Bar" treats.
Consumers who have unused or partially used packages of any of these products should return them to their place of purchase for a complete refund.

All "BLUE" dry natural food for dogs and "Spa Select" dry natural foods for cats are not affected by this recall and are safe for consumption. Should consumers have a specific question, they can call the Company at 1-800-919-2833, Monday through Friday, 9 a.m. to 5 p.m. EDT, to receive more information.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Chenango Valley Pet Foods Expands Voluntary Nationwide Recall of Certain Pet Foods
Contact:
Dennis J. Bobita
(610) 821-0608

FOR IMMEDIATE RELEASE -- May 17, 2007 -- Chenango Valley Pet Foods previously recalled dry pet foods manufactured with a shipment of rice protein concentrate supplied by Wilbur-Ellis that possibly contained melamine contamination. Chenango Valley Pet Foods is now expanding the recall action to include those pet foods that do not contain rice protein concentrate but were manufactured during periods when rice protein concentrate formulas were processed. The recall of these products is precautionary due to the possibility of cross-contamination.

The following dry pet foods are involved in this recall action:

*DOCTORS FOSTER & SMITH LAMB & BROWN RICE FORMULA ADULT DOG FOOD, NET WT. 6 LBS. (UPC 25141 28244), 15 LBS. (25141 30074), and 30 LBS. (UPC 25141 06043); Date Codes: Best By Feb 09 09 and Best By Feb 26 09;

*SHOP RITE REDI-MIXT DOG FOOD FOR DOGS, NET WT. 25 LB. (UPC 41190 00555), Date Code: Code C7107;

*LICK YOUR CHOPS KITTEN & CAT FOOD, NET WEIGHT 4 LBS. (UPC 32976 25915), and 18 LBS. (UPC 32976 25925); Date Code: Best Used By April 29 08;

*SHEP chunk style dog food, NET WT. 20 LBS. (UPC 41498 14142); Date Code: Best By March 14 08;

*8 in 1 Ferret ULTRA-BLEND ADVANCED NUTRITION DIET, NET WT. 20 LBS, UPC 26851 00413, Code: C7072;

*Bulk Lamb & Brown Rice Formula Dog Food, Date Code: Feb 09, 08, sold to one consignee SmartPak.

*Health Diet Cat Food Chicken & Rice Dinner NET WT. 1.81 kg/4 LB (UPC 78198 01594), 4 kg/8.8 LB (UPC 78198 01599), and 8 kg/17.6 LB (UPC 78198 01585); Code C7072;

*EVOLVE KITTEN FORMULA, NET WT. 3 LBS. (UPC 73657 00250) and 7 LBS. (UPC 73657 00251); Date Code: Best Used By Sept 13 08. Evolve has recovered 99.5% of the product from its distributors and is working with dealers to recover the remaining inventory.

No illnesses or injuries related to these products have been reported to date.

Pet owners who have purchased the pet foods listed above should immediately discontinue using the products and return them to the place of purchase for full refund. Pet owners should consult with a veterinarian if they have any health concerns with their pet. Consumers with questions may contact the company at 1-610-821-0608.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Nutra Nuggets 40 Lb. Lamb Meal and Rice Formula Recalled Due to Cross Contamination
Contact:
Customer Information Center
1-866-214-6945

FOR IMMEDIATE RELEASE -- Meta, MO -- May 23, 2007 -- Diamond Pet Foods announced that it has recalled a limited quantity of Nutra Nuggets 40 Lb. Lamb Meal and Rice Formula because of confirmatory testing that indicates the product may include traces of melamine resulting from cross contamination during manufacturing. No animal deaths have been reported.

This action is limited to Nutra Nuggets 40 Lb. Lamb Meal and Rice Formula with production codes of NLR0404A2SL, "Best Before" Oct. 9, 2008, and NLR0404B2SL, "Best Before" Oct. 9, 2008. The recalled product was manufactured at the company's Lathrop, Calif. facility. No other Nutra Nuggets products are affected.

Consumers who purchased Nutra Nuggets 40 Lb. Lamb Meal and Rice Formula with production codes of NLR0404A2SL, "Best Before" Oct. 9, 2008, and NLR0404B2SL, "Best Before" Oct. 9, 2008, should stop feeding the product immediately and return unused portions to their retailer for a full refund. Consumers may also contact the Diamond Pet Foods Customer Information Center toll free at 1-866-214-6945 for further information. The Center, which is staffed by veterinarians, is open Monday through Friday from 8:00 a.m. to 7:00 p.m. CDT.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

FDA Press Release


This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



FOR IMMEDIATE RELEASE
P07-91
May 24, 2007
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Warning on Mislabeled Monkfish
Fish Believed to be Puffer Fish; Contains Deadly Toxin

The Food and Drug Administration (FDA) is warning consumers not to buy or eat imported fish labeled as monkfish, which actually may be puffer fish, containing a potentially deadly toxin called tetrodotoxin. Eating puffer fish that contain this potent toxin can result in serious illness or death.

Tetrodotoxin is not destroyed by common food preparation or storage, such as cooking or freezing. Monkfish do not contain tetrodotoxin.

The product was imported and distributed by Hong Chang Corp., Santa Fe Springs, Calif.

Consumers concerned that they may have purchased this fish should contact their retailer and ask if the product was received from Hong Chang Corp.

The product should not be eaten, it should be thrown away. Care should be exercised in handling the fish, as the tetrodotoxin may be present on the skin and flesh of the fish. Consumers should wash hands thoroughly after handling the fish.

Two people in the Chicago area became ill after consuming homemade soup containing the fish. One was hospitalized due to severe illness.

FDA's analysis of the fish confirmed the presence of potentially life-threatening levels of tetrodotoxin.

Initial symptoms of tetrodotoxin poisoning occur 30 minutes to several hours after food containing the toxin is consumed. Tetrotoxin poisoning is characterized initially by tingling of the lips and tongue. Tingling of the face and extremities and numbness follow. Subsequent symptoms may include headache, balance problems, excessive salivation, nausea, vomiting, diarrhea and abdominal pain. Consumers experiencing these symptoms should seek immediate medical care and are encouraged to report their illness to local health authorities. In severe cases, muscles can become paralyzed, and death may follow from respiratory muscle paralysis.

A total of 282 22-pound boxes labeled as monkfish were distributed to *********rs in Illinois, California and Hawaii beginning in September 2006. These fish were then sold to restaurants or sold in stores. In one instance, the retailer labeled the fish as "bok," the Korean name for puffer fish.

The white 22-pound boxes were labeled in black ink. One box panel is labeled as: "FROZEN MONKFISH GUTTED AND HEAD-OFF" and "PRODUCT OF CHINA." A second panel bears nutritional facts and the following: "Ingredients: Monk fish; Imported by: Hong Chang Corp, Santa Fe Springs, CA 90670; Product of China (P.R.C.)." A third panel has a checkbox indicating the size as either "0.5-1" or "1-2" and shows the net weight as 22 pounds. There are no manufacturing codes on the box. The fish in the box are individually wrapped in plastic bags with no labeling.

FDA allows puffer fish to be imported into the United States only under strict provisions that minimize the risk of the toxin being present in the fish. The recalled fish were not imported in compliance with those restrictions. FDA is examining all entries from the Chinese supplier and will take additional action, if warranted.

####

Firm Press Release (May 23, 2007)

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Whole Foods Market Issues Nationwide Recall of 365 Organic Everyday Value Sesame Tahini
Contact:
Kate Lowery
(512) 542-0390

FOR IMMEDIATE RELEASE -- Austin, TX -- May 22, 2007 - Whole Foods Market is voluntarily recalling 365 Organic Everyday Value Sesame Tahini 16-oz, with a Best By Date of 10/02/07 or earlier because it has the potential to be contaminated with Salmonella.

Food contaminated with Salmonella may not look or smell spoiled. Consumption of food contaminated with this bacteria may cause salmonellosis, a foodborne illness. In young children, the elderly and people with weakened immune systems, salmonellosis may cause serious and sometimes deadly infections. In otherwise healthy people, salmonellosis may cause short-term symptoms such as high fever, severe headache, vomiting, nausea, abdominal pain and diarrhea. Long-term complications may include severe arthritis.

365 Organic Everyday Value Sesame Tahini was distributed nationally through Whole Foods Market retail stores. The product comes in a 16-oz glass jar with the UPC number 0009948240599. The Best By Date is located on the top of the lid of the jar, any Best By Date of 10/02/07 or earlier is being recalled. No confirmed illnesses have been reported to date.

Potential salmonella contamination was brought to the attention of Whole Foods Market by the product's manufacturer. As a result, the company is voluntarily recalling this product as a precautionary measure and has put additional safety measures in place. No other Whole Foods Market Private Label products have been affected by this recall.

Consumers who have purchased 365 Organic Everyday Value Sesame Tahini can return it to Whole Foods Market for a full refund. Questions may be directed to the Company by calling (512) 477-5566 x20656 or via email at privatelabel.customerservice@wholefoods.com.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



FOR IMMEDIATE RELEASE
P07-93
May 26, 2007

Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA




Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution
The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.

The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).

Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.

"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."

Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.

Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.

It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr.

"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."

All contact lens users should closely adhere to the following measures to help prevent eye infections:

Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
Wash hands with soap and water and dry them before handling contact lenses.
Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional.
Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
Schedule regular eye exams with your eye care professional
Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
Store lenses in a proper storage case.
Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use.
Replace storage cases at least once every three months.
FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.

Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



nSpired Natural Foods Issues Nationwide Recall of Maranatha Sesame Tahini Because of Possible Health Risk
Contact:
Lisa Wolford
646.805.2014

FOR IMMEDIATE RELEASE -- (San Leandro, CA, May 25, 2007) nSpired Natural Foods of San Leandro, California is voluntarily recalling all MaraNatha Sesame Tahini in 16-oz sizes with a Use By Date of 04/11/08 and earlier, and 15-lb and 32-lb sizes with an expiration date of 01/05/08 (lot 07130) and earlier, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstance, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

MaraNatha Sesame Tahini was distributed nationally through distributors, retail stores, and mail order.

MaraNatha Sesame Tahini comes in a 16-oz glass jar, and 15-lb and 32-lb pails. Products affected are Organic Raw Sesame Tahini, Organic Roasted Sesame Tahini, Natural Raw Sesame Tahini and Natural Roasted Sesame Tahini.

There have been no confirmed cases of illness to date.

Potential salmonella contamination was discovered during routine, random sample testing by the Canadian Food Inspection Agency. As a result, the company is voluntarily recalling this product as a precautionary measure and has put additional safety measures in place. No other products produced by the company, which include Almond Butter, Peanut Butter, Cashew Butter and Macadamia Nut Butter, are affected by this action.

Consumers who have purchased MaraNatha Sesame Tahini are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-883-8312.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

[GinaMarie]

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html



Abbott Announces Voluntary Nationwide Recall of Three Lots of Two-Ounce Bottles of Similac Special Care 24 Cal / fl. oz. Ready-to-Feed (RTF) Premature Infant Formula with Iron
Contact:
Consumer Hotline
888-899-9182

FOR IMMEDIATE RELEASE -- Columbus, OH -- May 25, 2007 -- Abbott's Ross Products Division today announced a voluntary nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal / fl. oz. Ready-to-Feed (RTF) Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital. This product is sold in eight unit cartons of two-ounce plastic bottles in the United States, and is primarily sold through pharmacies at the direction of a health care professional. It is not commonly available on retail store shelves.

Abbott is voluntarily recalling these three lots because they do not contain as much iron as indicated on the label. No serious medical complaints have been reported.

Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake. If parents have any concerns about their baby's health, they should contact their baby's doctor or health care professional.

The recall is limited to stock code number 59582 with lot numbers 46815D5, 47847D5 or 52023D5 printed on the outside carton and case and the lot numbers 44427X8, 4427X81 or 50005X8 printed on the bottom of the bottles. No other liquid or powdered Similac infant formulas are affected.

The three lots of infant formula were distributed in the United States between November 2006 and May 2007. Consumers who purchased Similac Special Care 24 Cal / fl. oz. RTF Premature Infant Formula with Iron from any of the specific lots mentioned above should contact Abbott's Ross Products Division at 1-888-899-9182. Ross will replace product from these lots free of charge.

Similac Special Care 24 Cal / fl. oz. RTF Premature Infant Formula is a highly specialized formula used by premature infants for a limited amount of time after discharge from the hospital. The impacted product is not used in hospitals.

Abbott is working with the U.S. Food and Drug Administration and its distribution partners to execute this recall.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html