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          FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Whole, Live Scallops Believed to Be Harvested from a Prohibited Area in Massachusetts and Distributed by Intershell International Corp (MA 7802 SP)Alerts, Advisories & Safety Information FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Whole, Live Scallops Believed to Be Harvested from a Prohibited Area in Massachusetts and Distributed by Intershell International Corp (MA 7802 SP)
  
  	
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Restaurants and food retailers in Illinois (IL), Massachusetts (MA), New Jersey (NJ), New York (NY), and Pennsylvania (PA) that have recently purchased certain Intershell International Corp (MA 7802 SP) whole, live scallops that were received from an unlicensed harvester, believed to be harvested from prohibited waters in MA and incorrectly labeled as harvest location FED 514, with harvest dates 12/26/23, 12/27/23 and 01/01/24.
	Consumers in IL, MA, NJ, NY, and PA who have recently purchased or consumed certain Intershell International Corp (MA 7802 SP) whole, live scallops, that were received from an unlicensed harvester, believed to be harvested from prohibited waters in MA and incorrectly labeled as harvest location FED 514, with harvest dates 12/26/23, 12/27/23 and 01/01/24.Product

Certain whole, live scallops that were received from an unlicensed harvester, believed to be harvested from prohibited waters in MA and incorrectly labeled as harvest location FED 514, with harvest dates 12/26/23, 12/27/23 and 01/01/24 that were distributed to IL, MA, NJ, NY, and PA. It is possible that these scallops may have been distributed to other states as well.

Purpose

The US Food and Drug Administration (FDA) is advising consumers not to eat, and restaurants and food retailers not to sell, and to dispose of certain Intershell International Corp (MA 7802 SP) whole, live scallops that were received from an unlicensed harvester, believed to be harvested from prohibited waters in MA and incorrectly labeled as harvest location FED 514, with harvest dates 12/26/23, 12/27/23 and 01/01/24 because they may be contaminated. The scallops were directly distributed to distributors and retailers in IL, MA, NJ, NY, and PA and may have been distributed further from these states.

Scallops harvested from prohibited waters may be contaminated with human pathogens, toxic elements or poisonous or deleterious substances and can cause illness if consumed. Scallops are filter feeders that remove and bioaccumulate bacteria and other pathogens from the water. It is not uncommon for shellfish to be consumed raw and whole. Contaminated scallops can cause illness if eaten raw and whole, or with viscera or roe attached, particularly in people with compromised immune systems. Scallops contaminated with pathogens may look, smell, and taste normal.

Symptoms of Food Poisoning

People can get sick with food poisoning after ingesting pathogens, toxic elements, or poisonous or deleterious substances. Symptoms may vary, depending on the pathogen or contaminant and can range from mild to serious. The most common symptoms of food poisoning are diarrhea, stomach pain or cramps, nausea, vomiting, and fever. Symptoms may start within a few hours or may take a few days and can last for a few hours or several days. Consumers of these products who are experiencing food poisoning symptoms such as diarrhea, stomach pain or cramps, nausea, vomiting, or fever should contact their healthcare provider, who should report their symptoms to their local Health Department.

Summary of Problem and Scope

On 01/05/2024, the Massachusetts Department of Public Health informed the FDA that certain whole, live scallops from Intershell International Corp (certified dealer number, MA 7802 SP) were allegedly harvested from a prohibited area and potentially contaminated. The scallops were received from an unlicensed harvester, believed to be harvested from prohibited waters in MA, and incorrectly labeled as harvest location: FED 514, with harvest dates 12/26/23, 12/27/23 and 01/01/24. These whole, live scallops were directly distributed to distributors and retailers in IL, MA, NJ, NY, and PA and may have been distributed further from these states.

On 01/09/2024, the Massachusetts Department of Public Health provided to the FDA notice of recall initiated by Intershell International Corp for certain whole, live scallops that were “received from an unlicensed harvester, allegedly harvested from a prohibited area in MA” and incorrectly labeled as harvest location: FED 514, with harvest dates 12/26/23, 12/27/23 and 01/01/24, and informed the Interstate Shellfish Sanitation Conference who subsequently notified the other member states. The states are continuing to conduct trace forward investigations. The FDA is assisting with and coordinating interstate notification efforts as a result of the states’ investigations.

FDA Actions

The FDA is issuing this alert advising consumers not to eat, and restaurants and food retailers not to sell, certain Intershell International Corp (MA 7802 SP) whole, live scallops received from an unlicensed harvester, believed to be harvested from prohibited waters in MA and incorrectly labeled as harvest location FED 514, with harvest dates 12/26/23, 12/27/23 and 01/01/24. The FDA is awaiting further information on distribution of the scallops and will continue to monitor the investigation and provide assistance to state authorities as needed.

Recommendations for Restaurants and Retailers

Restaurants and retailers should not serve or sell the potentially contaminated whole, live scallops. Restaurants and retailers should dispose of any products by throwing them in the garbage or returning them to their distributor for destruction.

Restaurants and retailers should also be aware that shellfish may be a source of pathogens and should control the potential for cross-contamination of food processing equipment and the food processing environment. They should follow the steps below:

Wash hands with warm water and soap following the cleaning and sanitation process.
	Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products need to be concerned about cross-contamination of cutting surfaces and utensils through contact with the potentially contaminated products.
	Retailers that have sold bulk product should clean and sanitize the containers used to hold the product.
	Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination.Recommendations for Consumers

Consumers should not eat the potentially contaminated whole, live scallops. Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event (illness or serious allergic reaction), you can:

Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
	Complete an electronic Voluntary MedWatch form online.
	Complete a paper Voluntary MedWatch form that can be mailed to FDA.Visit CFSAN’s Food & Cosmetic Information Center (FCIC) for additional consumer and industry assistance.


Additional Information

Notice of Illness Outbreaks, Shellfish Closures, Reopenings, & Recalls - ISSC
	Norovirus
	The Symptoms of Norovirus
	Preventing Norovirus
	Information on *Salmonella*
	Information on *E. coli*
	Handwashing: A Healthy Habit in the Kitchen

                                                                                  Content current as of:
      01/10/2024
              
              
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