Two Salmonella Strains In Sushi Outbreak – 200 Ill

The outbreak of Salmonella illnesses traced to eating sushi containing contaminated raw yellowfin tuna known as Nakaochi scrape has grown to encompass 200 confirmed illnesses in 21 states and the District of Columbia. Vermont was the latest state to be added to the list.

There is no longer even the slightest shadow of a doubt that the scrape yellowfin – which resembles ground tuna – is the source of this outbreak. Both FDA and the state of Wisconsin have confirmed the Salmonella Bareilly outbreak strain in food samples.

Two days ago, Wisconsin’s Department of Agriculture Trade and Consumer Protection laboratory reported confirming the presence of the outbreak strain of Salmonella Bareilly in the recalled yellowfin tuna and in a spicy tuna roll made with the recalled tuna. The DNA fingerprinting of the Salmonella was carried out by the Wisconsin State Laboratory of Hygiene, located at the University of Wisconsin – Madison.

Earlier today, FDA chimed in with its own announcement. FDA labs reported finding the Salmonella Bareilly outbreak strain in a sample of Nakaochi scrape yellowfin tuna obtained from a distributor of the raw fish product. The same sample contained a strain of Salmonella Nchanga that was indistinguishable from bacteria isolated from an additional cluster of 10 infections in 5 states. FDA also recovered Salmonella Bareilly from a sample of Nakaochi scrape yellowfin tuna obtained from a different distributor.

As a result of FDA’s lab findings, CDC has expanded its definition of the outbreak to include both Salmonella Bareilly and Salmonella Nchanga.

The raw tuna product was imported from India. On April 19th, FDA’s New Delhi office initiated a seafood (HACCP) inspection of the manufacturer’s facility (Moon Fishery Pvt Ltd, Aroor, India). The agency was informed that April 12, 2012 was the last day of tuna processing at the firm due to the seasonal nationwide ban on tuna harvest from the Indian Ocean. FDA has promised to post the inspection results once the report has been finalized.

CDC advises retailers and establishments not to serve raw recalled frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation. Establishments and retailers should check with their suppliers to confirm the source of the tuna product.

CDC offers the following Advice to Consumers

Do not eat the recalled frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation. This product is tuna backmeat that is scraped from the bones of tuna and may be used to make sushi, particularly “spicy tuna” sushi.
If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape tuna product from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation. When in doubt, don’t eat it.
Persons who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape tuna product should consult their healthcare providers.
Infants, older adults, pregnant women, and persons with impaired immune systems are more likely than others to develop severe illness and should not eat raw or partially cooked fish or shellfish. If you are unsure of your risk, ask your healthcare provider.

Wisconsin Ag Lab Finds Salmonella Bareilly In Recalled Tuna

Wisconsin’s Department of Agriculture Trade and Consumer Protection lab has recovered Salmonella from a sample of recalled tuna and from a spicy tuna roll made with the recalled tuna. The state’s Laboratory of Hygiene confirmed that the Salmonella found in both of these samples matches the DNA fingerprint of the outbreak strain of Salmonella Bareilly that has sickened more than 160 people in 20 states and the District of Columbia.

Moon Marine USA Corporation recalled 58,828 lbs of Nakaochi Scrape AA or AAA – a frozen raw yellowfin tuna product – on April 13th after epidemiological and traceback investigations carried out by federal, state and local authorities linked the product to a multistate outbreak of Salmonella Bareilly illnesses. The raw tuna product, which resembles ground tuna, was imported into the USA from India. FDA also issued two Import Alerts (#16-81 and #16-133) authorizing the detention without physical examination of fresh and frozen tuna from Moon Fishery India Pvt Ltd, the producer of the contaminated tuna meat.

The recalled product was not distributed for retail sale to consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores. While the company name and “Nakaochi Scrape AA or AAA were printed on boxes of product supplied to distributors, the tuna may not be readily identifiable by consumers as being from implicated lots.

News of the Salmonella Bareilly outbreak first broke on April 3rd. As of the CDC’s last update (April 20th), 26 people are known to have been hospitalized out of the 160 confirmed case patients. Reported onset dates for illnesses range from January 28th to April 10th. The youngest outbreak victim is 4 years of age; the oldest is 78 years old. Two-thirds of the confirmed case patients are female.

Confirmed cases of Salmonella Bareilly illnesses have been reported mainly from the eastern half of the continental USA; the westernmost cases are in Texas. Wisconsin has confirmed 15 cases in three counties, including Milwaukee (6 cases), Washington (2 cases) and Waukesha (7 cases). Three Wisconsin residents were hospitalized; all 15 have recovered from their illnesses.

FDA has this advice for consumers:

Because raw seafood is not fully cooked to assure that pathogens are destroyed, it is not considered as “safe” as cooked seafood. The handling of raw seafood can also affect the safety of the product. Because the tuna may have been broken into unmarked sublots and may not be readily identifiable, consumers should take precautions in choosing to eat raw Nakaochi Scrape and be sure that it is not from the implicated lots.
If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it.
Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.

Excedrin Return Still Months Away

Novartis hopes to gradually restart production at its Lincoln, Nebraska manufacturing plant as early as May, and resume shipping some products at mid-year. But a return to full production will probably not happen until 2013.

Production will restart on a line-by-line basis, according to David Epstein, Division Head of Novartis Pharmaceuticals, who offered a status update during the Novartis 1st Quarter 2012 Earnings Conference Call earlier today (April 24th)

“[W]e are in the middle of quality remediation activities at Lincoln,” Epstein said, “and we are making good progress. We had a meeting with the FDA recently, and shared with them our startup plan for the plant. We will begin production in May and we will resume shipments mid year.”

Epstein indicated that the “ramp up” would be slower than expected. “We’ll have a relatively limited portfolio in the back half of the year. So we have signed up some third-party manufacturers for some key products,” he explained. Neither Epstein nor any other participant in the conference call specified the order in which Excedrin and other products manufactured at that plant would reappear. Nor was there any indication as to which products would be farmed out to third-party manufacturers.

Novartis suspended production at its Lincoln facility on January 8, 2012 and recalled more than 125 million bottles of Excedrin and other OTC medications after a FDA inspection revealed flagrant and long-standing deficiencies in the company’s quality assurance and consumer complaint procedures. The shutdown of the Lincoln plant also has affected availability of a number of veterinary products, including Interceptor, a popular medication for preventing heartworm in dogs and cats.

I asked FDA for a description of the steps usually undertaken in a situation such as this one. After making the usual disclaimer that “FDA does not comment on an ongoing investigation,” Shelly Burgess of FDA’s Office of Public Affairs offered the following explanation:

“FDA investigators conduct routine inspections at drug manufacturing facilities to determine, among other things, compliance with the current good manufacturing practice regulations. When the investigator finds significant deviations from those minimum standards, he or she lists the deviations on a document called a form FDA 483, or the “483,” and issues that to the manufacturer at the conclusion of the inspection. By providing this notice, the Agency gives a manufacturer the opportunity to take voluntary and prompt corrective action. The manufacturer may submit a written response to the Agency explaining how it has corrected the violations or plans to do so, or explain why it disagrees with any of the listed observations. In most cases, manufacturers comply voluntarily but in some instances FDA sends the manufacturer a warning letter or an untitled letter. In addition, where appropriate, FDA may pursue enforcement action such as seizure and injunction.”

“The timeline can vary considerably depending on the extent of the corrective actions that are required for the firm to achieve compliance and demonstrate sufficient controls over manufacturing to produce acceptable quality drugs. Some deficiencies can be corrected within hours or days of notification such as when re-training an employee or fixing a piece of equipment. Other corrective actions may take days or months, such as qualifying a complicated manufacturing operation or validating a new test method.”

It’s not surprising that the restart in Lincoln will be slower than Novartis had originally hoped, or that the company is being vague regarding which products will receive priority when production at the facility resumes. No one wants a repeat of the problems that led to the recalls and shutdown.

Nevertheless, the delay will result in additional headaches for consumers, pharmacists, doctors, and veterinarians as the product shortages continue.