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CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Cyclospora infections. At this time, there is no evidence to suggest that this cluster of illnesses is related to the  Cyclosporaoutbreak linked to Del Monte fresh produce vegetable trays.

As of August 23, 2018 (12pm EDT), a total of 507 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states and New York City. Note, the Connecticut, New York City, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.

Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 21). Ill people range in age from 14 to 91 years old, with a median age of 52. Sixty-six percent (66%) are female. At least 24 people have been hospitalized; no deaths have been reported.

Illnesses that started after July 12, 2018 might not have been reported yet due to the time it takes between when a person becomes ill and when the illness is reported. For Cyclospora infections, this can take up to six weeks.

Epidemiologic evidence indicates that salads purchased from McDonald’s restaurants are one likely source of these infections. The investigation is ongoing, and FDA is working to determine the sources of the ingredients that were in common to the salads served at McDonald’s.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

As of August 16, 2018 (3pm EDT), a total of 476 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states. Note, the Connecticut, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.  Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 20). Ill people range in age from 14 to 91 years old, with a median age of 53. Sixty-six percent (66%) are female. At least 21 people have been hospitalized; no deaths have been reported.

Epidemiologic evidence indicates that salads purchased from McDonald’s restaurants are one likely source of these infections. The investigation is ongoing, and FDA is working to determine the sources of the ingredients that were in common to the salads served at McDonald’s.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

The CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Cyclospora infections. As of August 9, 2018 (11am EDT), a total of 436 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states. Note, the Connecticut, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.

Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 20). Ill people range in age from 14 to 91 years old, with a median age of 53. Sixty-six percent (66%) are female. At least 20 people have been hospitalized; no deaths have been reported.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

What is Cyclospora?

Cyclospora is a parasite composed of one cell, too small to be seen without a microscope. The organism was previously thought to be a blue-green alga or a large form of cryptosporidium. Cyclospora cayetanensis is the only species of this organism found in humans. The first known human cases of illness caused by cyclospora infection (that is, cyclosporiasis) were first discovered in 1977. An increase in the number of cases being reported began in the mid-1980s, in part due to the availability of better diagnostic techniques. Over 15,000 cases are estimated to occur in the United States each year. The first recorded Cyclospora outbreak in North America occurred in 1990 and was linked to contaminated water. Since then, several cyclosporiasis outbreaks have been reported in the U.S. and Canada, many associated with eating fresh fruits or vegetables. In some developing countries, cyclosporiasis is common among the population and travelers to those areas have become infected as well.

Where does Cyclospora come from?

Cyclospora is spread when people ingest water or food contaminated with infected stool. For example, exposure to contaminated water among farm workers may have been the original source of the parasite in raspberry-associated outbreaks in North America.

Cyclospora needs time (one to several weeks) after being passed in a bowel movement to become infectious. Therefore, it is unlikely that Cyclospora is passed directly from one person to another. It is not known whether or not animals can be infected and pass infection to people.

What are the typical symptoms of Cyclospora infection?

Cyclospora infects the small intestine (bowel) and usually causes watery diarrhea, bloating, increased gas, stomach cramps, and loss of appetite, nausea, low-grade fever, and fatigue. In some cases, vomiting, explosive diarrhea, muscle aches, and substantial weight loss can occur. Some people who are infected with Cyclospora do not have any symptoms. Symptoms generally appear about a week after infection. If not treated, the illness may last from a few days up to six weeks. Symptoms may also recur one or more times. In addition, people who have previously been infected with Cyclospora can become infected again.

What are the serious and long-term risks of Cyclospora infection?

Cyclospora has been associated with a variety of chronic complications such as Guillain-Barre syndrome, reactive arthritis or Reiter’s syndrome, biliary disease, and acalculous cholecystitis. Since Cyclospora infections tend to respond to the appropriate treatment, complications are more likely to occur in individuals who are not treated or not treated promptly. Extraintestinal infection also appears to occur more commonly in individuals with a compromised immune system.

How is Cyclospora infection detected?

Your health care provider may ask you to submit stool specimen for analysis. Because testing for Cyclospora infection can be difficult, you may be asked to submit several stool specimens over several days. Identification of this parasite in stool requires special laboratory tests that are not routinely done. Therefore, your health care provider should specifically request testing for Cyclospora if it is suspected. Your health care provider might have your stool checked for other organisms that can cause similar symptoms.

How is Cyclospora infection treated?

The recommended treatment for infection with cyclospora is a combination of two antibiotics, trimethoprim-sulfamethoxazole, also known as Bactrim, Septra, or Cotrim. People who have diarrhea should rest and drink plenty of fluids. No alternative drugs have been identified yet for people with Cyclospora infection who are unable to take sulfa drugs. Some experimental studies, however, have suggested that ciprofloxacin or nitazoxanide may be effective, although to a lesser degree than trimethoprim-sulfamethoxazole. See your health care provider to discuss alternative treatment options.

How can Cyclospora infection be prevented?

Avoiding water or food that may be contaminated is advisable when traveling. Drinking bottled or boiled water and avoiding fresh ready-to-eat produce should help to reduce the risk of infection in regions with high rates of infection. Improving sanitary conditions in developing regions with poor environmental and economic conditions is likely to help to reduce exposure.

Washing fresh fruits and vegetables at home may help to remove some of the organisms, but Cyclospora may remain on produce even after washing.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Cyclospora outbreaks. The Cyclospora Attorneys and Lawyers have represented victims of Cyclospora and other foodborne illness outbreaks and have recovered over $650 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.

If you or a family member became ill with a Cyclospora infection after consuming food and you are interested in pursuing a legal claim, contact the Marler Clark Hepatitis A attorneys for a free case evaluation.

Fresh Express Statement about Recall of a Limited Number of Cases of Expired Products Not Marked or Labeled for Retail Sale:

At Fresh Express, our top priority is providing consumers with the highest quality and safest fresh lettuce and leafy greens products available.

In its investigation, the US Food and Drug Administration (FDA) took several random samples of products and one sample, yielded a positive result for Cyclospora. Although the sample taken was an already-expired institutional foodservice product, it none-the-less necessitated a precautionary recall by Fresh Express on July 27th of a limited number of cases.

The products recalled were packaged in clear plastic, multi-pound packs that did not display the Fresh Express logo and were not marked or labeled for retail sale to consumers.

The Fresh Express food safety team, along with our outside food safety experts, have collaborated closely with FDA, the US Centers for Disease Control and Prevention and state public health agencies in their outbreak investigations, and we continue to do so. As of now, there is no clear understanding about the contamination pathway or the definitive source of infection.

Fresh Express follows rigid food safety requirements and preventive controls throughout our supply chain that are carefully designed to mitigate against potential health risks. Working together with public health officials, we are hopeful a definitive source of the outbreak clusters will be identified soon.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert out of an abundance of caution due to concerns about contamination with Cyclospora. The beef, pork and poultry salad and wrap products were distributed by Caito Foods LLC, an Indianapolis, Ind. establishment.

The beef, pork and poultry salad and wrap items were produced between July 15 to 18, 2018, with the either “Best By,” “Enjoy by,” Best if Sold By” or “Sell By” dates ranging from July 18 through July 23, 2018. [View Label (PDF only)]

The complete list of products, product labels, the UPC code numbers and other identifying information can be found here.

The products bear establishment number “EST. 39985 or P-39985” inside or next to the USDA mark of inspection. These items were shipped to distribution centers nationwide.

The problem was discovered when Caito Foods LLC received notification from their lettuce supplier, Fresh Express, that the chopped romaine that is used to manufacture some of their salads and wraps was being recalled.

FSIS is concerned that some product may be in consumers’ refrigerators and that consumers may be at risk due to the length of the Cyclospora incubation period. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. Caito Foods LLC and FSIS are working together to remove the products from commerce.

Anyone concerned about an illness should contact a health care provider. Cyclospora infection is an illness cause by the intestinal parasite, Cyclospora cayetanensis. The incubation period for Cyclospora ranges from two to 14 days, which would include the dates of July 25 through August 6, 2018. Illnesses might not have been reported yet due to the time it takes between when a person becomes ill and when the illness is reported. For Cyclospora infections this could take up to six weeks.

As of July 24, 2018, 77 people infected with the outbreak strain of Salmonella Adelaide were reported from nine states. A list of the states and the number of cases in each can be found on the Case Count Map page.

Illnesses started on dates ranging from April 30, 2018, to July 2, 2018. Ill people ranged in age from less than 1 year to 97, with a median age of 67. Among ill people, 67% were female. Out of 70 people with information available, 36 (51%) were hospitalized. No deaths were reported.

Epidemiologic and traceback evidence indicated that pre-cut melon supplied by the Caito Foods, LLC of Indianapolis, Indiana was the likely source of this multistate outbreak.

Information collected from stores where ill people shopped indicated that Caito Foods, LLC supplied pre-cut melon to these stores. On June 8, 2018, Caito Foods, LLC recalled fresh-cut watermelon, honeydew melon, cantaloupe, and fresh-cut fruit medley products containing one of these melons that were produced at the Caito Foods facility in Indianapolis, Indiana.

cyclosporaoutbreak_406x250Food Safety News reports that Texas officials are investigating an increasing number of Cyclospora parasite infections, asking for help from health care providers and warning the public that fresh produce is the possible source.

As of Thursday, 72 cases had been confirmed in the state, said Press Officer Christine Mann. That’s up from the 55 cases reported Monday in a health advisory from the state health department.

“Within the past month, 55 cases of Cyclospora infection have been reported to the Texas Department of State Health Services,” according to the advisory from state Health Commissioner Dr. John Hellerstedt.

“Rapid reporting to public health, enabling prompt investigation to identify possible common exposures, is essential to preventing additional cases of cyclosporiasis this year.”

State officials are recommending a series of lab tests for everyone who has symptoms of Cyclospora infection.

“Diagnosis of cyclosporiasis requires submission of stool specimens for ‘Ova and Parasite’ testing with additional specific orders for Cyclospora identification. A single negative stool specimen does not exclude the diagnosis; three specimens are optimal,” according to the advisory.

Symptoms usually begin two days to two weeks after ingestion of Cyclospora oocysts in contaminated food or water. Profuse diarrhea can last weeks to months and may relapse. Additional symptoms may include anorexia, fatigue, weight loss, abdominal cramps, bloating, increased gas, nausea, vomiting and low-grade fever.

outbreak_map_8_25_2015As of August 21, 2015, CDC had been notified of 495 ill persons with confirmed Cyclospora infection from 30 states in 2015.

Most of these persons—293 (59%) of 495—experienced onset of illness on or after May 1, 2015, and did not have a history of international travel within 2 weeks before illness onset. These 293 persons were from the following 23 states: Arkansas (3), California (2), Connecticut (3), Florida (10), Georgia (23), Illinois (8), Iowa (1), Kansas (2), Maryland (1), Massachusetts (10), Michigan (2), Missouri (1), Montana (3), Nebraska (1), New Jersey (6), New Mexico (2), New York (excluding NYC) (9), New York City (21), North Carolina (1), Texas (168), Utah (1), Virginia (3), Washington (2), and Wisconsin (10).

  • Clusters of illness linked to restaurants or events have been identified in Texas, Wisconsin, and Georgia.
  • Cluster investigations are ongoing in Texas and Georgia.
  • Cluster investigations in Wisconsin and Texas have preliminarily identified cilantro as a suspect vehicle.
  • Investigations are ongoing to identify specific food item(s) linked to the cases that are not part of the identified clusters.

Previous U.S. outbreaks of cyclosporiasis have been linked to imported fresh produce, including cilantro from the Puebla region of Mexico. Read the related FDA Import Alert.

According to Texas, its count is 243.

Canada counts 87.

outbreak_map_2015bCanadians ill too.

As of August 10, 2015 (3pm EDT), CDC had been notified of 457 ill persons with confirmed Cyclospora infection from 29 states in 2015.  Most of these persons—275 (60%) of 457—experienced onset of illness on or after May 1, 2015, and did not have a history of international travel within 2 weeks before illness onset. These 275 persons were from the following 22 states: Arkansas (2), California (2), Connecticut (3), Florida (11), Georgia (22), Illinois (6), Iowa (1), Kansas (2), Maryland (1), Massachusetts (9), Michigan (2), Missouri (1), Montana (3), Nebraska (1), New Jersey (6), New Mexico (1), New York (excluding NYC) (8), New York City (21), Texas (157), Utah (1), Virginia (3), Washington (2), and Wisconsin (10).

Clusters of illness linked to restaurants or events have been identified in Texas, Wisconsin, and Georgia.

Cluster investigations are ongoing in Texas and Georgia.

Cluster investigations in Wisconsin and Texas have preliminarily identified cilantro as a suspect vehicle.

Investigations are ongoing to identify specific food item(s) linked to the cases that are not part of the identified clusters.

Previous U.S. outbreaks of cyclosporiasis have been linked to imported fresh produce, including cilantro from the Puebla region of Mexico. Read the related FDA Import Alert.

Public health officials are warning about an outbreak of the intestinal illness Cyclospora, with 83 cases are being investigated across Canada.  The Public Health Agency of Canada has issued a statement that says two people have been hospitalized from the parasite but no deaths have been reported.  The cases became known between May 9 and July 18 and are mainly in Ontario, but there are also some infections in B.C., Alberta and Quebec.

cilantroAs of August 3, 2015 (4pm EDT), CDC had been notified of 384 ill persons with confirmed Cyclospora infection from 26 states in 2015.

  • Most (226; 59%) ill persons experienced onset of illness on or after May 1, 2015 and did not report international travel prior to symptom onset.
  • Clusters of illness linked to restaurants or events have been identified in Texas, Wisconsin, and Georgia.
  • Cluster investigations are ongoing in Texas and Georgia.
  • Cluster investigations in Wisconsin and Texas have preliminarily identified cilantro as a suspect vehicle.
  • Investigations are ongoing to identify specific food
    item(s) linked to the cases that are not part of the identified clusters.

Previous U.S. outbreaks of cyclosporiasis have been linked to imported fresh produce, including cilantro from the Puebla region of Mexico. Read the related FDA Import Alert issued July 27, 2015.