15-State E. coli Outbreak Triggers Recall

Rich Products Corporation (Buffalo, NY) has recalled more than 196,000 pounds of frozen chicken quesadilla and various other heat-treated, not fully cooked frozen mini meals and snack items in the wake of an outbreak of 24 confirmed cases of E. coli O121 illnesses in 15 US states.

Eight of the outbreak victims - residents of Michigan, Mississippi, New York, Ohio, Pennsylvania, Texas and Virginia - reported consuming Farm Rich brand products. The New York Department of Health found the outbreak strain of E. coli O121 in a sample of Farm Rich frozen chicken mini quesadilla product obtained from a victim in that state. USDA is working with state and federal public health agencies - including FDA and CDC - on this outbreak investigation. CDC has not yet released a complete list of the 15 states.

E. coli O121 is one of six non-O157 Shiga toxin producing E. coli serogroups that is recognized by the USDA as an adulterant in certain raw beef products.

The manufacturer has recalled the following products in cooperation with USDA's Food Safety and Inspection Service (items 1-4) and FDA (items 5-7):

1. Farm Rich mini pizza slices with cheese pepperoni and sauce in pizza dough (7.2-oz cartons; UPC 041322376909; Best by date May 15 or May 16, 2014)
2. Farm Rich mini pizza slices with cheese pepperoni and sauce in pizza dough (22-oz cartons; UPC 041322356437 Best by date May 15 or May 16, 2014)
3. Farm Rich mini quesadillas with cheese, grilled white meat chicken in a crispy crust (18-oz bags; UPC 041322356352; Best by date of May 14, 2014)
4. Farm Rich philly cheese steaks with cheese, beef & onions in a crispy crust (21-oz bags; UPC 041322356345; Best by date May 13, 2014)
5. Farm Rich mozzarella bites in a pizzeria style crust (22-oz cartons; UPC 041322374431; Best by date of May 19, 2014)
6. Farm Rich mozzarella bites in a pizzeria style crust (7-oz cartons; UPC 041322376916; Best by date of May 19, 2014)
7. Market Day Mozzarella Bites (22-oz bags; UPC 041322804358; Best by date of May 12, 2014)

The recalled products were manufactured between November 12, 2012 and November 19, 2012 and supplied to Walmart for nationwide distribution. Consumers who may have purchased any of the recalled products should check their freezers and discard these items, or return them to Walmart.

According to USDA, infection with E. coli O121 can result in dehydration, bloody diarrhea and abdominal cramps 2-8 days (3-4 days, on average) after exposure to the organism. While most people recover within a week, some develop a type of kidney failure called HUS, Hemolytic Uremic Syndrome. This condition can occur among persons of any age but is most common in children under 5-years old and older adults. Symptoms of HUS may include fever, abdominal pain, pale skin tone, fatigue, small, unexplained bruises or bleeding from the nose and mouth, decreased urination, and swelling. Persons who experience these symptoms should seek emergency medical care immediately.

Belgian Cheese Recall Goes Multinational

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A couple of months ago - March 19th to be precise - Belgomilk (Moorslede, Belgium) announced the recall of a single lot of Nazareth Classic rectangular "half-cheese" (approx. 3Kg, plastic-wrapped; Lot ID #0520018301 or 0520018302). The recalled cheese was distributed in Belgium and Germany (RASFF Reference #2011.0374).

The reason for the recall? The company found Listeria monocytogenes in a sample of this batch of cheese.

About a month later, France notified RASFF (Rapid Alert System for Food and Feed) member countries that it had detected Listeria monocytogenes in a sample of cheese from Belgium (RASFF Reference #2011.0511; released 18/04/2011 and updated 11/05/2011). The Alert indicated that there had been "distribution to other member countries."

It, therefore, should not have come as a shock when Belgomilk announced a greatly expanded cheese recall on May 10th, as a result of having found Listeria monocytogenes in an unspecified number of production lots of cheese manufactured at its Moorslede facility. The new recall encompassed cheeses purchased by consumers prior to May 11th.

This list of recalled cheeses includes the following brands and formats:

• Affligem Tranches/Affligem Slices, ± 400g


• Belgolight Jeune/Belgolight Young, 200g


• Brugge d'Or Tranches/Brugge d'Or Slices, ±375g


• Brugge d'Or Bloc/Brugge d'Or Wedge, ±450g/250g


• Corsendonk Cubes, 250g


• Grimbergen Tranches/Grimbergen Slices, ±350g


• Grimbergen Cubes, ±315g


• KV Light Fromage Tranches/KV Light Cheese Slices (Light 16% fromage jeune/Light 16% young cheese), ±300g


• Nazareth Classic Bloc/Nazareth Classic Wedge, ±425g/250g


• Nazareth Classic Cubes, 150g/250g


• Nazareth Classic Tranches/Nazareth Classic Slices, 200g/180g


• Nazareth Light Tranches/Nazareth Light Slices, ±300g


• Nazareth Tranches/Nazareth Slices, 200g/150g


• St. Maarten Classic Tranches/St. Maarten Classic Slices, 200g

In addition, the following cheeses were sold "cut to order" at creameries or dairy stands, and as "freshpack" cheese in supermarkets: Belgolight, Bocholter fromage à pain, Brugge d'Or and Nazareth Light & Classic.

Part of the Milcobel dairy cooperative, Belgomilk is headquartered in Kallo, Belgium, and is the largest milk processor in the Milcobel corporate family. Its three factories produce a variety of milk products, including milk powders, butters and cheeses. The Moorslede location produces Belgomilk's branded and Gouda-style cheeses for distribution in Belgium and for export.

According to the RASFF notification (EU #2011.0619) - issued on May 11, 2011 and updated on May 13, 2011 - the cheeses that were recalled by Belgomilk on May 10th were distributed in Belgium, Canada, France, Germany, the Netherlands, Portugal, the Russian Federation, Spain, the United Kingdom and the United States.

The RASFF notice does not specify which brands of cheese may have been distributed in which countries. Nevertheless, some of this information can be gleaned from recall notices posted by individual countries. The following list is current, as of May 14th.

Belgium

Recalled cheeses were distributed in Colruyt, OKay, Spar, Alvo and Delhaize stores, as follows:

• Grimbergen Tranches/Slices, ±350g (Colruyt & OKay)


• Grimbergen Cubes, ±315g (Colyruyt, OKay, Alvo & Spar)


• Affligem Tranches/Slices, ±400g (Colyrut & OKay)


• Bruges d'Or Trances/Slices, ±375g (Colyrut & OKay)


• Bruges d'Or Bloc/Wedge, ±400g (Colyrut & OKay)


• Nazareth Classic Bloc/Wedge, ±425g (Colyrut & OKay)


• Nazareth Fromage en Block/Wedge Cheese, ±250g (Delhaize)


• Nazareth Light Tranches/Slices, ±300g (Colyrut & OKay)


• Kievit Light Tranches/Slices, ±300g (Colyrut & OKay)


• Delhaize Tranches de Nazareth/Nazareth Slices, 180g (Delhaize)


• Delhaize Plateau de fromage Belgo-Français/Belgo-France Cheese Platter, ±400g (Delhaize)


• Brugge Kaas Plateau de fromage Brugge/Brugge cheese platter ±450g (Delhaize)

Germany

The following recalled cheese was sold in Lidl stores in North Rhine-Westphalia and Lower Saxony only:

• St. Maarten Classic Belgian Cheese Slices, 200g

Luxembourg

The following recalled cheeses were sold in member stores of the Colruyt group in Luxembourg:

• Grimbergen Tranches/Slices, ±350g (Colruyt, Collivery & OKay)


• Grimbergen Cubes, ±315g (Colyruyt, Collivery, OKay, Alvo & Spar)


• Affligem Tranches/Slices, ±400g (Colyrut, Collivery & OKay)


• Bruges d'Or Trances/Slices, ±375g (Colyrut, Collivery & OKay)


• Bruges d'Or Bloc/Wedge, ±400g (Colyrut, Collivery & OKay)


• Nazareth Classic Bloc/Wedge, ±425g (Colyrut, Collivery & OKay)


• Nazareth Light Tranches/Slices, ±300g (Colyrut, Collivery & OKay)


• Kievit Light Tranches/Slices, ±300g (Colyrut, Collivery & OKay)

The Netherlands

• St. Maarten Classic Belgian Cheese Slices, 200g - sold in Lidl stores in the Netherlands

United Kingdom

• St. Maarten Classic Belgian Cheese Slices, 200g - sold in Lidl stores in the UK

Not all countries and retailers are equally prompt at posting recall notices - if they post them at all. If you have purchased one of the recalled cheeses and your country or store does not appear on the above lists, please discard the cheese and let me know where you found it, so that I can add the information to the list for the benefit of other consumers.

Periodic updates to this recall list will be posted only on the eFoodAlert WordPress site.

Cilantro Products Recall List To Grow

Salmonella-contaminated batch of cilantro supplied to several companies

(Updated November 11th with additional distribution information)

On November 3rd, EpicVeg, Inc. (Lompoc, CA) notified customers that it was recalling one lot of fresh cilantro (UPC 033383801049; Lot #6127R), after learning that the cilantro was contaminated with Salmonella. EpicVeg, according to the Company's web site, is "...a vertically integrated grower/shipper of California Vegetables located on the central coast of California."

The recalled lot of cilantro – as is typical in the US food processing industry – navigated through a variety of distribution channels. Some of the cilantro was distributed to Field Fresh Foods, Inc. (Los Angeles, CA). Field Fresh supplied the cilantro to Orval Kent Food Company and several other customers. Some of the recalled cilantro was supplied to APPA Fine Foods (Corona, CA), either directly from EpicVeg, through Field Fresh, or via some other as-yet-unnamed third party.

Emelio Castañeda, President of Field Fresh Foods, provided eFoodAlert with a copy of the letter sent out to Field Fresh customers. The letter contains the following information:

"The affected products have the potential of contamination with Salmonella from fresh cilantro that originated at EpicVeg Inc. The cilantro was distributed to us at Field Fresh Foods and we then supplied to Orval Kent Foods and several other customers that we have contacted directly. The cilantro was found in one lot from EpicVeg (Number 6127R) and the Food and Drug Administration notified affected parties on Nov. 3."

The California Department of Public Health reports that some of the recalled cilantro was distributed to retailers in California, and has posted a list of retail locations where the product was sold. Cilantro recalled by Fresh Field was supplied to Picnic People (Camino Ruiz, San Diego, CA) and to 13 El Pollo Loco restaurant outlets in El Segundo, Santa Ana, Garden Grove, Torrance, Orange, Hawthorne, Anaheim, Long Beach, Costa Mesa, Rialto and Tustin.

FDA did not require EpicVeg to issue a pubic recall notice, as the Company supplied the affected cilantro to just four distributors (including Field Fresh Foods), and contacted all four directly. "Instead," I'm told by FDA spokesperson Siobhan DeLancey, "the companies further downstream are doing releases, because they have the products (and labeling) that consumers will be able to recognize."

Following is a list of the "further downstream" products that have been recalled. I have included retail distribution information, where available. This list will be updated as more recalls are announced.

• Bistro 28 Cranberry Mango Pico de Gallo.- UPC 7945388187; Use by 12/12/2010; Available in all Sam's Club stores in California, all Trader Joe's stores in California and several Costco stores in California.
• CA Pizza Kitchen BBQ Chopped Chicken Salad.- UPC 7978185105; Use by 11/24/2010, 11/25/2010, 11/27/2010, 12/1/2010, 12/2/2010; Available in all Sam's Club stores in California, all Trader Joe's stores in California and several Costco stores in California.
• Chef Solutions Mexican 5 Layer Dip 12 oz.- UPC 77509663208; Use by 12/11/2010.
• Fish House Foods Ceviche 5 lb.- UPC 1345435529; Use by 10/30/2010, 12/7/2010;
• Fish House Foods Fajita Chicken Salad Kit 1 lb.- UPC 1345435800; Use by 1/20/2011, 2/4/2011
• Fish House Foods SW Fajita Bean Salad w Chk.- UPC 1345437117; Use by 11/21/2010
• Fry's Krab Ceviche Fry 12 oz.- UPC 1345435301; Use by 12/9/2010; Distributed to Fry's stores (a member of the Kroger Company group)
• Orval Kent Chipotle Chicken Pasta Kit.- UPC 1345435574; Use by 1/2/2011
• Orval Kent Cilantro Pecan Dip 8 oz.- UPC 7945330215; Use by 12/1/2010
• Orval Kent Southwest Fajita Bean Salad with Chicken, 5lb.- Sold in Kroger stores in Texas and Louisiana
• Spicy Thai Style Pasta Salad 12 oz.- Manufactured by APPA Fine Foods (Corona, CA); Sell by 10/31/2010 through 11/6/2010; SKU 74441; distributed to Trader Joe's retail stores in California (Fontana and Stockton), Arizona (one Tucson store) and Nevada (one store in Reno and one store in Carson City)
• Trader Joe's Cilantro Dressing 12 oz.- SKU 36420; Use by 2/9/2011; distributed to all Trader Joe's stores nationwide
• Trader Joe's Cilantro Pecan Dip 7 oz.- SKU 76986; Use by 11/20/2010, 11/24/2010; distributed to Trader Joe's stores in California, Arizona, New Mexico, Nevada, Oregon, and Washington.
• Trader Joe's Spicy Peanut Vinaigrette 12 oz.- SKU 80947; Use by 1/9/2011; distributed to all Trader Joe's stores nationwide

Walmart has posted the Orval Kent recall notice, indicating that one or more of the products were sold at Sam's Club, but has not specified which of the recalled products are carried by Sam's Club.

Fish House Foods products were supplied to Fish House Vera Cruz locations in San Marcos, Carlsbad and Temecula, California.

What consumers should do:

• Avoid ready-to-eat products that contain cilantro as an ingredient, unless you are certain that the cilantro came from a source other than EpicVeg (such as a local grower).
• If you have consumed a product that contains cilantro – especially a salad or a dip – and you believe that you developed a Salmonella infection within a few days of having consumed the product, please contact your family doctor and your local or state department of health.
• If you have purchased one of the recalled products, either discard the item or return it to the store for a refund.

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Bravo Farms Recalls Cheese Implicated In Outbreak

All lot codes below 0233 included in recall

Bravo Farms (Traver, CA) has recalled its Dutch Style raw milk Gouda Cheese, because the cheese may be contaminated with E. coli O157:H7. All lot codes below 0233 are encompassed by the recall notice, which is dated November 7, 2010 and was posted today on Costco's web site.

The recalled cheese was distributed mainly through Costco in Southern California (one San Diego County store), Nevada, Arizona, Utah, Colorado and New Mexico in 1.5 lb pieces. The Gouda also was distributed through various (unnamed) retail stores within California in 8-ounce pieces.

Bravo Farms' Dutch Style Gouda cheese is implicated in a five-state outbreak of E. coli O157:H7 illnesses. FDA and the state of California have initiated an investigation at Bravo Farms.

Illnesses related to this outbreak have been reported in Arizona, California, Colorado, New Mexico and Nevada. A rare strain of E. coli O157:H7 – one that has never before been reported to CDC's PulseNet data base for foodborne pathogens – has been recovered from outbreak patients. The strain has been characterized by CDC as EXHX01.2292/EXHA26.0621, based on the "genetic fingerprint" method known as Pulsed Field Gel Electrophoresis.

An opened package of the implicated cheese that was purchased at Costco by one of the outbreak patients has been found to contain E. coli O157:H7. As of November 5th (the date of the most recent CDC report), it was not clear whether or not this strain was identical to the outbreak strain that had infected 25 outbreak victims.

The largest single cluster of outbreak cases was reported in Arizona. According to information provided by Carol Vack, a spokesperson for the Arizona Department of Health Services, eleven Arizona residents – five females and six males – have been confirmed to be part of the outbreak. The victims range in age from 2 years old to 78 years old. Six of the Arizona victims have been hospitalized. Arizona is continuing to investigate, and Ms. Vack warns that the number of cases can change daily.

A lawsuit against Bravo Farms already has been filed on behalf of one of the Arizona victims, Annette Sutfin of Maricopa County. According to the Complaint, on October 15th, Ms. Sutfin consumed a sample of the implicated cheese at a Costco Warehouse store in Phoenix. She began to develop symptoms of E. coli O157:H7 infection on October 18th and sought treatment at a hospital emergency room on October 21st. Ms. Sutfin was hospitalized on October 23rd, received treatment, and was discharged on October 25th. She continue to suffer from gastrointestinal symptoms throughout the balance of October and into November and is still recovering.

California has recorded just one outbreak case, a six-year old girl living in San Diego County. Colorado's eight cases are spread over three counties; New Mexico's three victims – a four-year old boy, a seven-year old girl and a 41-year old man – live in two different counties. Nevada has released no details about its two cases.

Both CDC and FDA expect to issue updates as more information becomes available.

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Unscrambling The Egg Mess: The Latest Developments

CDC updates numbers; FDA "warns" Wright County Egg, gives green light to Hillandale

Two weeks ago, CDC told me that it planned – "by the end of the week"– to release an update to its report on the Salmonella Enteritidis outbreak investigation. Yesterday, they delivered.

From May 1st to October 15, 2010, CDC estimates that 1,813 illnesses are likely to be associated with the consumption of Salmonella Enteritidis-contaminated eggs from Wright County Egg (also known as Quality Egg LLC) and Hillandale Farms of Iowa.

CDC typically receives approximately 1,369 reports of illnesses due to this very common strain of Salmonella during the May 1st to October 15th timeframe (based on a five-year average). This year, the agency has received 3,182 reports. The estimate of 1,813 illnesses represents the difference between this year's reports and the five-year average.

This graph, taken from the CDC investigation report, profiles the outbreak on a week-by-week basis. The solid line represents the five-year average number of cases.

The outbreak numbers appear to tail off during the last four weeks, but this is not necessarily the case. As the graph explains, the area in grey represents a time period during which new illnesses may have occurred but have not yet been diagnosed and reported to CDC.

What can we deduce from this graph?

1. The outbreak did not start on May 1st. It likely began much earlier – perhaps in February/March. The number of cases per week appears to start tracking noticeably above the baseline average as early as the last week of January.
2. The outbreak peaked in June/July. CDC identified the outbreak in July, when it was already at its peak. The number of cases began to drop off in August, even before the first recall was initiated.
3. The outbreak did not end with the August recalls of eggs from Wright County Egg and Hillandale Farms. Even in mid-September, the number of reported cases continued to track well above the 5-year average baseline.

What has FDA been doing?

Hillandale Farms of Iowa:- FDA performed a follow-up inspection of Hillandale's West Union facility from October 13 to 15th, and has permitted Hillandale to resume the distribution of shell eggs, based on the following understanding:

• Hillandale's agreement to clean and disinfect houses 1 & 2 prior to repopulation;
• Hillandale's commitment to comply with the requirements of the Egg Safety Rule, including egg testing from houses with environmental Salmonella-positives;
• FDA's confirmation of the corrections to the problems noted in the agency's August 2010 inspection (see FDA-483 report)
• Consistent negative Salmonella Enteritidis test results from the environment and from eggs at houses 3, 5 and 7 in the West Union facility.
• Commitment not to ship table eggs from houses 4, 6, 8 & 9 until they go through four rounds of egg testing. These eggs will be held and shipped once all four rounds of testing are completed satisfactorily.
• Monthly environmental testing of houses 4, 6, 8 & 9 for the life of the current flock.

Wright County Egg (Quality Egg, LLC):- FDA issued a Warning Letter to Austin Decoster, the owner of Quality Egg LLC on October 15th, based on the agency's inspection report and its subsequent discussions with the Company. It's clear from the Warning Letter that FDA is not yet satisfied with Decoster's response to the agency's findings. After reciting a summary of the deviations noted in its FDA-483 report, FDA closed with the following statements:

This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the shell egg regulation, and the PHS Act. You also have a responsibility to use procedures to prevent further violations.

You should take prompt and aggressive actions to eliminate the Salmonella Enteritidis contamination and the observations described in this letter. Failure to take prompt corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure and/or injunction.

FDA is in receipt of your response dated October 5,2010, to the FDA-483 and additional information you submitted reflecting ongoing discussions with the agency of your corrective actions. We acknowledge your commitment to correcting the deviations and will verify your corrections via inspection.

As for the rest of the shell egg industry, FDA has begun its first round of "routine" inspections under the new Egg Safety Rule. I reported two weeks ago, that the first inspections were completed in Maine in late September. The focus then shifted back to the Midwest. FDA has not indicated any plans to release the results of these inspections – unless, of course, they result in recalls or warning letters.

Until FDA decides to release the results of its inspections, our household is sticking with Eggland's Best!

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Revisiting The Blue Buffalo Dog Food Recall

Stories behind the story

When an animal receives an excessive amount of vitamin D in its diet, it develops a condition known as Hypervitaminosis D, or vitamin D toxicity. What is the significance of vitamin D toxicity, and when should a dog owner suspect that a canine family member is suffering from this condition? Here is the answer that I found in the 1996 textbook Clinical Endocrinology of Dogs and Cats: An Illustrated Text, by Adam Rijnberk. I've inserted "translations" of technical terms in square brackets where appropriate.

"Hypervitaminosis D may result from excessive supplementation of vit D in the diet..." It leads to increased formation of 25-OHD [a form of vitamin D], augmented calcium and phosphate absorption from the intestine, and increased calcium and phosphate reabsorption in the kidneys."

"The clinical picture may be dominated by one or more of the signs of hypercalcemia [elevated calcium] such as polydipsia/polyuria [excessive thirst/excessive urination], dehydration, weakness and anorexia [loss of appetite]. If complicated by renal insufficiency [inadequate kidney function], there may be vomiting and other signs of azotemia [abnormally high nitrogen compound levels in the blood]. Routine laboratory investigations will reveal that calcium and phosphate concentrations in plasma and urine are elevated."

Last Friday, researchers at Michigan State University (MSU) alerted pet owners to a link between Blue Buffalo dog food and 16 cases of excessive blood levels of Vitamin D in dogs. The sick dogs had increased thirst and urination; some of them also suffered weight loss, anorexia and signs of kidney damage.

MSU also announced that it was cooperating with FDA and the Michigan Department of Agriculture in an investigation of the dog food. Shortly after this announcement, Blue Buffalo recalled the following products:

• BLUE Wilderness Chicken Flavor: 4.5 lb; Best if used by JUL2611Z, JUL2711Z, JUL2811Z
• BLUE Wilderness Chicken Flavor: 11 lb; Best if used by JUL1211B
• BLUE Wilderness Chicken Flavor: 24 lb; Best if used by JUL1211B, JUL1311B
• BLUE Basics Limited Ingredient Formula Salmon and Potato Recipe: 11 lb; Best if used by AUG2111B, AUG2211B
• BLUE Basics Limited Ingredient Formula Salmon and Potato Recipe: 24 lb; Best if used by AUG2111B, SEP2311P, OCT2611P
• BLUE Life Protection Formula Natural Chicken & Brown Rice Recipe Large Breed Adult: 30 lb.; Best if used by SEP2211P, SEP2311P, OCT2611P

By the time the recall was announced, the known number of sick dogs had risen to 36.

In its recall notice, the Company explained that "...a sequencing error had occurred at the supplier of the dry ingredients for these products. Immediately before producing the ingredients for these specific production runs, the supplier had run a product for another customer that contained a more potent form of Vitamin D used in chicken feeds. It is now believed that there was some level of carry over of this Vitamin D product into the ingredients for the specific manufacturing runs of the BLUE products, thereby increasing the Vitamin D activity to unacceptable levels in the Blue ingredients."

Since posting the original story, I have received comments from some readers, who have described their own experiences with Blue Buffalo and its dog foods. Their descriptions hint at the possibility of additional problems with the company's products. Here is what they had to say.

From Las, who posted this comment on October 12th:

"We have two dogs on this food. They have only been on it since early August. Three weeks ago one of our dogs had a horrible kidney infection. Last night we took our "puppy" (19 months) to the vet because she started drinking so much water and then having accidents. The vet was a little worried and gave us a run if antibiotics and told us to watch her water intake for the next few days and bring her back at the end of this week.

This morning we got a panicked call from him telling us he treated another dog with the same symptoms and the owner had mentioned the food recall. He put two and two together and I have to bring in my girls later today to have lab work done. My girls are feeling very ill and you can tell they don't feel well either.

As for classy, I called Blue Buffalo and.... I wouldn't call the terrible customer service I got today "class"."

From Alice, who emailed me privately on October 11th:

"I had my three Goldendoodles on Blue Buffalo Life Protection Formula Chicken and Rice Adult. I had seen your notice of the recall on Blue Buff. food, and figured that since it was a different variety from the Life Protection, I was ok. however, the last 40 lb. bag I purchased had an inordinate quantity of their "Life Source Bits". Well over half of the bag was these "bits". Since they tout them as being the blend of antioxidants, vitamins and minerals, I was concerned that my dogs would get too much of a good thing and I decided to mix the food with another brand to balance the ingredients. In the meantime, I sent a request to Blue Buffalo asking if there would be a problem in feeding it to my dogs without mixing it and in the request, I asked for a prompt reply. I sent my request on 9-24-10 by email. I finally received a reply tonight, 10-10-10. Their reply will follow my long diatribe to you. It includes the text of my email to them. I do not store my dog food in the original bags, so do not have the bag from the food, nor do I have the receipt, however it was purchased at Petsmart and I can show the purchase date from my debit card transaction. I usually save the production information just in case, but for some reason unbeknownst to me, I didn't save it this time.

Now, my questions: What do I do next? I am no longer feeding it to my dogs, but have about half of the bag's quantity left. I do not want another bag of Blue Buffalo!! Is there someplace that I should report this to, and if so, who and where? Needless to say, I am not a happy camper!!"

Blue Buffalo offered the following explanation for Alice's experience, and suggested that she return the product to the retailer for an exchange.

"It sounds as if you may have purchased a bag from the beginning or end of a production run."

And from Anonymous, who posted this on October 13th:

"I wouldn't be surprised if they recall other flavors of their dog food too. My dog got horribly sick several times this summer and I narrowed it down to the Blue Buffalo Lamb & Brown Rice. I took it back to the store and they refunded me. I wish I still had it so they could test it."

My first reaction to Blue Buffalo's recall announcement was a favorable one – it's not often that a company immediately offers to reimburse "... any veterinary or testing expenses related to illness caused by..." a recalled product. But delays in responding to consumer complaints and comments about "terrible" customer service are worrisome. As is Blue Buffalo's complete lack of response to my request for information on the retail distribution of the recalled products.

In the absence of a response from Blue Buffalo, I have surveyed most of the pet supply chains listed on the company's Store Locater web page. I have found only two that have posted Blue Buffalo recall notices on their web sites – PetCo and Pet Supplies Plus. I encourage readers who purchased recalled product from other retailers to post the information below, or to email me directly with the information so that I can help to spread the word.

I hope Blue Buffalo realizes that its reputation for quality products and customer service will be harmed permanently if it does not respond promptly and effectively to complaints and questions. As Alice said in granting me permission to share her experience,

"I hope that Blue Buffalo's rush to enter the market with quality foods is the reason for the problems that they are having. I know they've spent a lot of time and money to introduce it and to promote it to the pet stores. Sloppy production practices may cost it dearly. I know I won't use any of their products again. I had such high hopes for them."

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Blue Buffalo Recalls Dog Foods LInked to Vitamin D Toxicity

Company blames ingredient supplier for excess Vitamin D (updated October 9th with link to FDA recall notice)

Blue Buffalo (Wilton, CT) has recalled three varieties of its dry dog foods after researchers at Michigan State University (MSU) linked Blue Buffalo Wilderness Chicken to reports of elevated blood levels of Vitamin D in 16 sick dogs from 8 different states.

The affected dogs all exhibited increased thirst and urination; some of them also suffered weight loss, anorexia and signs of kidney damage. They seemed to recover once their diet was changed.

Veterinarians had sent blood samples from their canine patients to MSU's Diagnostic Center for Population and Animal Health, according to Center Director Carole Bolin. Veterinarians also provided a patient history, which enabled MSU to determine that all 16 dogs routinely were fed Blue Buffalo Wilderness Chicken recipe. Once MSU researchers established the unequivocal link, they notified the company, the Michigan Department of Agriculture, and the FDA.

According to FDA, there have been a total of 36 cases reported nationwide. In all cases, the symptoms subsided after a change in diet, with no apparent long-term health consequences.

According to the company, this problem most likely derived from the action of an ingredient supplier, who produced a Vitamin D supplement immediately prior to preparing ingredients for Blue Buffalo. The company suspects that some of the Vitamin D inadvertently was carried over into Blue Buffalo's ingredients.

Once company management became aware of its ingredient supplier's scheduling error and the potential that excess Vitamin D had been incorporated into certain dog foods, Blue Buffalo recalled all of the following dry dog food products and date codes:

• BLUE Wilderness Chicken Flavor: 4.5 lb; Best if used by JUL2611Z, JUL2711Z, JUL2811Z
• BLUE Wilderness Chicken Flavor: 11 lb; Best if used by JUL1211B
• BLUE Wilderness Chicken Flavor: 24 lb; Best if used by JUL1211B, JUL1311B
• BLUE Basics Limited Ingredient Formula Salmon and Potato Recipe: 11 lb; Best if used by AUG2111B, AUG2211B
• BLUE Basics Limited Ingredient Formula Salmon and Potato Recipe: 24 lb; Best if used by AUG2111B, SEP2311P, OCT2611P
• BLUE Life Protection Formula Natural Chicken & Brown Rice Recipe Large Breed Adult: 30 lb.; Best if used by SEP2211P, SEP2311P, OCT2611P

The affected products were distributed across the USA through pet specialty stores. As Blue Buffalo also is sold in Canada, I urge both US and Canadian customers to check the Best if used by dates on the product packages listed above.

In a classy move that should be emulated by all food processors whose products are linked to illnesses – human or animal – Blue Buffalo has promised to reimburse its customers for any veterinary or testing expenses related to illness caused by these products.

I have also received the following statement from Larissa, on behalf of Blue Buffalo Co.

"To assure that this sort of mistake doesn’t occur again in the handling of our ingredients, we have required all of our manufacturing and ingredient partners to immediately put in place a system of cross checking and reporting, by multiple operators on site, to confirm that they have followed our protocol for all lines to be clear of any possible residue before running any of our products."

Without the services provided by a large veterinary diagnostic center such as the one located at MSU's East Lansing campus, it is unlikely that this problem would have been detected. The MSU lab performs more than 1.3 million diagnostic tests a year on samples received from all over the USA.

"Because of our nationwide reach and expertise," Director Bolin said, "we were able to discover this and notify the proper authorities."

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Recall Roundup: August 4, 2010

Here is today's list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

• Allergy Alert: Ugo DiLullo & Sons (Westville, NJ) establishment, is recalling approximately 147,667 pounds of U. DiLullo's Deluxe Meatballs in Sauce (6 lb., 10 oz. cans) because the product contains undeclared egg.
• Food Recall/Withdrawal: Food City announces the recall/withdrawal of Full Circle Organic Angel Hair Vermicelli (16 oz). No reason was given for the action.
• Pet Food Safety Recall: Merrick Pet Care, Inc. (Amarillo, TX) is extending its July 2,2010 recall of 10 oz "Beef Filet Squares for Dogs (Texas Hold'Ems)" pet treat (ITEM # 60016 LOT # 10084TL7 BEST BY MARCH 24, 2012) to also include 83 cases of "Texas Hold'ems" (ITEM # 60016 LOT # 10127 BEST BY MAY 6, 2012) because they have the potential to be contaminated with Salmonella.

Canada

• Allergy Alert: Mike's Bakery (Fredericton, NB) recalls Mike's Bakery brand Jelly Cookies (500g pkgs; all Best Before dates up to and including 8/24/10), because the Jelly Cookies contain milk, which is not declared on the label.
• Food Safety Recall (Update): Costco Canada advises its customers that the following three recalled Brandt ready-to-eat meats were sold in Costco Warehouse stores in Canada: Mini Farmer Sausage (Costco item# 206013), Turkey Drumsticks, smoked (Costco item# 39818), and Turkey Kolbassa (Costco item# 39141).

Europe

• Food Safety Recall (Czech Republic): Tins of codfish liver imported from Poland that are contaminated with higher than permitted levels of dioxins and PCBs are being cleared from supermarket shelves by food safety authorities in the Czech Republic. The agency has not released the names of the producers, but advises that the recalled products have best before dates between 30 November 2011 and 31 January 2013.
• Food Safety Notification (EU #2010.1065): Too high content of trans fatty acids in cherry pralinen from Hungary; distributed in Denmark.
• Food Safety Notification (EU #2010.1066): Unauthorized sulphite in quince jam from Spain; distributed in Spain.
• Food Safety Notification (EU #2010.1067): Unauthorised colour Sudan 1 in red pepper paste from Turkey; distributed in Germany.
• Food Safety Notification (EU #2010.1068): Carbon monoxide treatment of chunks of frozen swordfish (Xipias gladius) from Vietnam, via the Netherlands; distributed in Italy.

Australia and New Zealand

• Food Safety Recall Cancelled (Australia): Hunsa Smallgoods retracts its earlier recall of Hunsa Cacciatore Hot Salami (Use by 26 Aug 10). Further testing has confirmed that there was a laboratory error and this product does not contain Salmonella as indicated in the original test results.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket's recall web site.

• A&P
• Big Y® World Class Market®
  
• BJ's Wholesale Club, Inc.
  
• Bloom
  
• Brookshire's
  
• Costco Wholesale Corporation (US stores)
  
• Costco Wholesale Canada Ltd.
  
• EDEKA (Germany)
• Food City
  
• Food Lion
  
• Giant Food LLC
• Gros Cidac (Italy)
• Hannaford Brothers Co.
  
• Harris Teeter
  
• Harvey's Supermarket
  
• H-E-B
• The Kroger Company*
  
• Price Chopper
  
• Raley's
• Roundy's Supermarkets, Inc.
  
• Sainsbury's
  
• ShopRite
  
• Stop & Shop
• Sweetbay Supermarkets
• Target
  
• Top Food & Drug
• Tops Friendly Markets
  
• Wal-Mart Stores, Inc.
  
• Wegmans
  
• Whole Foods Market
  
• WinCo Foods
• Winn-Dixie Stores, Inc.
  

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.

French Sausage-Maker Expands Recall Of La Pause Auvergnate

Dried sausage implicated in national outbreak of salmonellosis in France

An outbreak of salmonellosis due to Salmonella Typhimurium (serotype 4,12 :i :- ) was traced late last month to contaminated dried sausages produced by the French sausage company Salaisons du Lignon, based in Saint-Maurice de Lignon (Haute Loire).

The outbreak, which was still under investigation as of May 28th, has sickened at least 88 people – 18 severely enough to require hospital treatment – in 49 départements throughout France. Illnesses were reported between March 15th and May 9th.

This particular Salmonella Typhimurium serotype first appeared in Europe in the mid 1990s; it now has become the second most common type of Salmonella reported by European Union member countries. Cases of salmonellosis associated with this type of Salmonella tend to be more severe than average, and result in a higher rate of hospitalization than is usual for Salmonella gastroenteritis.

Based on patient interviews, investigators from France's Institut de Veille Sanitaire traced the outbreak to a single production lot of Lou Montagnard brand La Pause Auvergnate style dried sausages (saucisses sèches droites nature La Pause Auvergnate). Salaisons du Lignon recalled the implicated production lot (Lot No. 040020900) – distributed both in France and in Belgium – on May 27th.

Yesterday (June 4th), without fanfare or explanation, Salaisons du Lignon expanded its recall in Belgium – but not yet in France – to encompass all product expiration dates up to and including 24/08/10. There have been no published reports of salmonellosis cases in Belgium that are tied to the French outbreak.

This progressive recall is reminiscent of the Daniele Italian-style salami recalls in the United States earlier this year. Daniele first recalled a limited number of products and date codes of its products after they were linked to a multi-state outbreak of Salmonella Montevideo. As the investigation proceeded, the list of recalled products grew until – at last – Daniele recalled more than 1.26 million pounds of meats.

In view of the expanded recall and in light of past experiences such as Daniele, I would question whether Salaisons du Lignon's Salmonella contamination problem is limited to just one style of sausage. Depending on the source of the contamination in the product (e.g., plant environment, raw ingredients, sanitation issues), the company may find it necessary to expand its recall to other products.

Consumers in France as well as Belgium would be well-advised to pay attention to the expanded recall that was announced in Belgium and to avoid all date codes of Lou Montagnard brand La Pause Auvergnate dried sausages – or to switch brands altogether until the manufacturer has been given a clean bill of health.

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Salmonella Outbreak Sickens 22 People in 10 States

Alfalfa sprouts contaminated with Salmonella Newport responsible for outbreak

CDC reports that alfalfa sprouts contaminated with Salmonella Newport were responsible for at least 22 illnesses in 10 states between March 1st and May 2nd of this year. The number of confirmed cases may increase as federal and state investigators continue to conduct DNA testing of Salmonella cultures recovered from patient samples.

As of today, illnesses associated with this outbreak have been reported by Arizona (1), California (11), Colorado (1), Idaho (1), Illinois (1), Missouri (1), New Mexico (1), Nevada (2), and Oregon (1). The Oregon victim is an infant. Four of the 22 victims – including the Oregon child – were hospitalized.

Caldwell Fresh Foods (Maywood, CA), the sprout manufacturer, has recalled all lots of Caldwell Fresh Foods, Nature's Choice, and California Exotics brands of alfalfa sprouts. According to Caldwell, the alfalfa sprouts were distributed to a variety of restaurants, delicatessens and retailers nationwide. In California, the recalled sprouts were sold at Kings Super Market, Numero Uno Stores, Cárdenas Markets, Trader Joe's Stores, Gonzalez Northgate Markets, Wal-Mart stores, Jons Markets, and Canton Foods.

If you have purchased alfalfa sprouts recently – and, especially if you live in one of the states where outbreak cases have been reported – please check the brand name on the package and discard any Caldwell Fresh Foods, Nature's Choice or California Exotics brands. If you experienced any symptoms of gastroenteritis (e.g., nausea, diarrhea, stomach cramps), after eating alfalfa sprouts, you should immediate medical attention and mention that you ate alfalfa sprouts.

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Nestlé Recalls Nescafé Collections Espresso

Instant coffee may contain glass fragments

Nestlé has recalled all lot codes of 100g jars of Nescafé Collections Espresso instant coffees due to a packaging problem.

The Collections Espresso line of instant coffees is packaged in a plastic-encased glass jar. According to recall notices posted by Nestlé and echoed on some government web sites, the glass jar may become damaged during transportation, and release glass fragments into the coffee powder.

Nestlé's recall includes all 100g jars of the following Nescafé products:

• Alta Rica (in France: Espresso Puissant et Corsé)
• Alta Rica Decaff
• Cap Colombie (in France: Espresso Doux et Fruité)
• Suraya
• Espresso

According to European Rapid Alert System for Food and Feed (RASFF) Notification #2010.0626, the recalled coffee was distributed in: Austria, Belgium, Bosnia and Herzegovina, Croatia, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Lithuania, the Netherlands, Norway, Poland, Portugal, Romania, the Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine and the United Kingdom.

In addition, Canada and Singapore have posted recalled notices on their websites.

While the glass fragments may not be noticeable in the coffee powders, consuming the recalled coffee could result in injury. Please either discard the recalled Nescafé Collections instant coffees or return them to the store where they were purchased.

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It's Not Just E. coli O157:H7 Anymore!

Industry and government must think outside the (Jack In The) Box

As many as 30 people in New York, Tennessee, Ohio and Michigan are suffering from gastroenteritis after consuming shredded romaine lettuce that was contaminated with E. coli O145, according to CDC. Twenty-three of the cases are confirmed; the other seven are described as "probable" cases.

Twelve of the victims have been hospitalized – three of them with hemolytic uremic syndrome (HUS). Fortunately, there have been no deaths so far.

The outbreak strain has been recovered from a previously unopened package of shredded romaine lettuce obtained from an institution that received the lettuce from Freshway Foods (Sidney, OH). Freshway, on May 6th, recalled all Freshway and Imperial Sysco brand products containing romaine lettuce with a use by date of May 12 or earlier.

The Freshway lettuce apparently was harvested from a farm in the area of Yuma, Arizona. Two other fresh produce distributors – Vaughan Foods (Moore, OK) and Andrew Smith Co. (Spreckels, CA) – also have initiated recalls.

E. coli O145, like its better known relative E. coli O157:H7, is one of more than 250 types of E. coli that produce shiga toxin – a toxin that causes dysentery-like symptoms and can trigger the life-threatening HUS syndrome. Shiga-toxin producing strains of E. coli are referred to collectively as STEC E. coli.

CDC recommends that clinical labs test patients simultaneously for both E. coli O157:H7 and for non-O157 STEC strains. But FDA, USDA, and the food industry focus on E. coli O157:H7, while ignoring other STEC strains. This is a shortsighted approach.

Non-O157 STEC E. coli have caused serious outbreaks of foodborne disease around the world, including:

• E. coli O111:H8 infected 55 attendees at a high school cheerleading camp in Texas in 1999.
• E. coli O111 was responsible for 23 cases of HUS and an additional 30 cases of bloody diarrhea in Australia in 1995; the outbreak was traced to contaminated sausages.
• E. coli O26:H11 infected 20 individuals in Denmark in 2007; an organic fermented beef sausage was the vehicle.
• Non-O157 STEC E. coli are more prevalent in Iran than the "traditional" E. coli O157:H7.
• New Mexico identified 111 cases of STEC E. coli between 2004 and 2007; 71 of the 111 cases were caused by non-O157 strains.
• A recent study in India found 16 cases of STEC E. coli infections out of 1000 stool samples tested; none of the isolates were E. coli O157:H7.
• E. coli O103:H2, E. coli O145:H28 and E. coli O174:H21 were recovered from farm residents suffering from diarrheal infections. These non-O157 STEC infections were traced to cattle.
• E. coli O111 – a non-O157 STEC E. coli – infected 341 patrons of the Country Cottage restaurant in Locust Grove, OK in 2008. Seventy people were hospitalized. One victim died.
• Two non-O157 STEC E. coli strains – E. coli O26:H11 and E. coli O80:H2 – were responsible for 16 cases of HUS in France. Camembert cheese made from raw milk was behind the 2005 outbreak. The STEC strains were recovered from the raw milk, from the cheese, and from the patients.

In 1996, David Acheson (FDA's former food safety czar) and Gerald Keusch wrote in ASM News:

"Whatever the serotype, if a bacterium is making Shiga toxins in the gastrointestinal tract of an infected individual, that person is at risk for developing [hemorrhagic colitis] and HUS."

USDA has been "studying" a petition to expand its definition of "adulterated meat" to include meat that is contaminated with non-O157 STEC E. coli.

The time for study is past. It's time to act.

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McNeil's Migraine

FDA releases inspection report for McNeil's Fort Washington, PA production plant; McNeil apologizes to consumers

It's not often that FDA issues a separate consumer warning in conjunction with a manufacturer's voluntary recall. So when I saw FDA's May 1, 2010 news release, I had a hunch that something was up.

In January of this year, McNeil recalled a broad range of OTC pharmaceuticals produced at its Puerto Rico manufacturing facility after an FDA inspection found numerous deficiencies in the plant's operations. As a result of the Puerto Rico problems, the company undertook a "... comprehensive quality assessment across its manufacturing operations..."

Unfortunately for McNeil and its customers, that comprehensive quality assessment had not yet paid dividends in the Fort Washington, PA manufacturing plant by the time FDA arrived to inspect the facility on April 19, 2010. FDA's inspection lasted from April 19th to April 30th, and uncovered a long list of operational deficiencies.

Here are just a few of the problems highlighted in the FDA report:

• Raw material ... had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products, which remain within expiration dates on the market.
• Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
• A thorough investigation or any additional analytical testing was not conducted for Infants Dye-Free Tylenol Suspension Drops, Cherry, 80 mg/0.8mL, Formula ... for ... lots that were super potent and confirmed to fail release specification of ... Acetominaphen (APAP) assay.
• There is no written testing program designed to assess the stability characteristics of drug products.
• Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.

In response to FDA's release of the 17-page inspection report, McNeil released the following statement:

We have no higher concern than providing parents with the highest quality products for their children. The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate. While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused. We will provide a detailed response to the FDA on their observations, and work diligently to ensure that they are addressed.

We have temporarily suspended production at our Fort Washington, PA plant, where the observations were made. We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there.

This step comes on top of others we already have taken to ensure quality compliance. Early this year we initiated a comprehensive assessment of quality and manufacturing systems across our operations. We have committed extensive internal resources to this effort, and brought in independent outside experts to assist us.

We will continue to work in close consultation with the FDA to take corrective action and ensure that our quality operations meet the high standards that consumers expect from us.

We remind consumers with questions about the recall of certain infants' and children's products to contact us at: www.mcneilproductrecall.com; or call us at 1-888-222-6036.

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Pesticides in Polish Peas Trigger International Baby Food Recall

Blédina recalls 10 products supplied to Europe, Africa, the Middle East, the Caribbean and Polynesia

On April 23rd, Blédina (a member of the Danone group) recalled three brands of baby food, explaining that a supplier error caused peas destined for general consumption to be mixed with peas destined for baby food products. The recall was publicized in France and in Belgium, and appeared in the eFoodAlert Recall Roundup on April 23rd and April 27th, respectively.

Thanks to the European Union's (EU) Rapid Alert System for Foods and Feeds (RASFF), we now have a more complete picture of this recall. On May 3rd, France notified RASFF of the presence of "fluazifop-P (0.149 mg/kg - ppm) in baby food containing green peas manufactured in France, with raw material from Poland."

Fluazifop-P is a pesticide, and EU regulations limit pesticide residues in baby foods to no more than 0.01 mg/kg-ppm. It is very likely that this baby food was manufactured – and subsequently recalled – by Blédina.

Blédina's recall notice encompassed the following products:

• Idées de maman (6 mois): Purée de petits pois (DLUO du 20 au 21 janvier 2011)
• Idées de maman (6 mois): Haricots verts Dinde (DLUO au 27 janvier 2011; du 9 au 11 février 2011; du 14 au 16 mars 2011)
• Idées de maman (8 mois): Panier de légumes Jambon (DLUO du 27 au 28 janvier 2011; du 3 au 5 mars 2011; au 16 mars 2011)
• Idées de maman (8 mois): Légumes du potager Bœuf (DLUO du 28 au 30 janvier 2011)
• Petit pot (6 mois): Légumes verts Poulet (DLUO au 15 décembre 2011; au 7 janvier 2011; au 27 janvier 2012)
• Petit pot (6 mois): Jardinière de légumes (DLUO au 12 novembre 2011; au 15 décembre 2011; au 27 janvier 2012)
• Petit pot (6 mois): Légumes verts Riz Saumon (DLUO au 23 novembre 2011; au 12 janvier 2012; au 14 janvier 2012; au 16 février 2012)
• Petit pot (8 mois): Jardinière légumes Poulet (DLUO au 6 janvier 2012; au 28 janvier 2012; au 2 février 2012)
• Blédichef (8 mois): Etuvée Haricots verts Poulet (DLUO au 20 avril 2011)
• Blédichef (12 mois): Sauté de petits pois Veau (DLUO au 11 mai 2011)

The pesticide-contaminated baby food was distributed in Belgium, Portugal, Spain, France, French Guiana, French Polynesia, Guadeloupe, Martinique, Lebanon, Congo-Brazzaville, Côte d'Ivoire, Djibouti, Gabon, Liberia, Mali, Mauritius, Mayotte, New Caledonia, and Niger. Not all of the products would have been shipped to every country. Belgium, for example, received only one item, "Blédichef (8 mois) Haricots verts Poulet DLUO au 20 avril 2011."

Consumers living in the countries listed above and who purchased Blédina's Petit Pot, Blédichef or Idées de Maman brands of baby food should check their pantries and discard any items that are mentioned on the recall list.

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McNeil's May Day: Children's Tylenol, Motrin, Zyrtec & Benadryl Products Recalled

Quality issues at manufacturing plant triggers May 1st recall of all unexpired production batches

McNeil Consumer Healthcare has recalled all unexpired lots of the following over-the-counter (OTC) medications:

• CONCENTRATED TYLENOL® INFANTS’ DROPS – various sizes and flavors
• CHILDREN’S TYLENOL® SUSPENSION – various sizes and flavors
• CHILDREN’S TYLENOL® DYE-FREE SUSPENSION, 4 oz. – Cherry flavor
• CHILDREN’S TYLENOL® PLUS SUSPENSION, 4 oz. – various varieties (including dye-free) and flavors
• CONCENTRATED MOTRIN® INFANTS’ DROPS – various sizes; Berry and dye-free Berry flavors
• CHILDREN’S MOTRIN® SUSPENSION – various sizes and flavors
• CHILDREN’S ZYRTEC® liquids – various sizes, varieties (including dye-free and sugar- and dye-free) flavors
• CHILDREN'S BENADRYL® ALLERGY, 4 oz. – Bubble gum flavored liquid

Two of the recalled items – Concentrated Tylenol® Infants' Drops (0.5 oz. Grape Flavor) and Concentrated Motrin® Infants' Drops (0.5 oz. Berry Flavor) – also are included in JOHNSON'S® Baby Relief Kit. McNeil Consumer Healthcare is a Johnson & Johnson company.

The recalled OTC products were sold in the United States, Canada, the Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

FDA has supplemented the McNeil recall notice with a separate news release containing guidance for consumers, and providing the following explanation for this recall:

"McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use."

Today's recall represents the latest in a series of safety and quality recalls that have bedeviled McNeil's manufacturing operations since an FDA inspection of the company's Puerto Rico production facility – conducted between October 22, 2009 and January 8, 2010 – uncovered significant problems at that location.

According to a report on MarketWatch, the products covered by today's recall were manufactured in a Pennsylvania production facility, and not in the Puerto Rico plant. Additional details on this, and earlier, McNeil product recalls can be accessed on a special McNeil website at www.mcneilproductrecall.com.

Consumers or health professionals wishing to report an adverse reaction to one of the recalled products can do so using FDA's MedWatch program.

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