Posted in FDA, FDA Enforcement Report, FDA Warning Letter, Salmonella
June 5, 2024
Certain oysters and bay clams harvested from OR growing areas in Netarts Bay and Tillamook Bay, harvested on or after 5/28/24, and shellfish species from growing areas in Willapa Bay, WA: Stony Point, harvested between 5/26/24 and 5/30/24; Bay Center, harvested between 5/29/24 and 5/30/24; and Bruceport, harvested between 5/29/24 and 5/30/24. The shellfish were distributed to restaurants and retailers in AZ, CA, CO, HI, NV, NY, OR, and WA and may have been distributed to other states as well.
The FDA is advising restaurants and food retailers not to serve or sell and to dispose of, and consumers not to eat, oysters and bay clams harvested from growing areas in Netarts Bay and Tillamook Bay, OR harvested on or after 5/28/24, and all shellfish species from growing areas in Willapa Bay, WA: Stony Point, harvested between 5/26/24 and 5/30/24; Bay Center, harvested between 5/29/24 and 5/30/24; and Bruceport, harvested between 5/29/24 and 5/30/24, and distributed to AZ, CA, CO, HI, NV, NY, OR, and WA because they may be contaminated with the toxins that cause paralytic shellfish poisoning (PSP).
Molluscan shellfish contaminated with natural toxins from the water in which they lived can cause consumer illness. Most of these toxins are produced by naturally occurring marine algae (phytoplankton). Molluscan shellfish consume the algae which causes the toxins to accumulate in the shellfish’s flesh. Typically, contamination occurs following blooms of the toxic algal species; however, toxin contamination is possible even when algal concentrations are low in certain instances. One of the recognized natural toxin poisoning syndromes that can occur from consuming contaminated molluscan shellfish is paralytic shellfish poisoning (PSP).
PSP is caused by neurotoxins also referred to as saxitoxins or paralytic shellfish toxins (PSTs). Shellfish can retain the toxin for different lengths of time. Some species cleanse themselves of toxins rapidly, whereas others are much slower to remove the toxins. This lengthens the period of time they pose a human health risk from consumption.
Food containing PSTs may look, smell, and taste normal. These toxins cannot be removed by cooking or freezing. Consumers of these products who are experiencing symptoms of illness should contact their healthcare provider and report their symptoms to their local Health Department.
Posted in Algal Toxin, FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Poisoning, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Food Toxin, Lipophilic Marine Biotoxin, Marine Biotoxin, paralytic shellfish poisoning, PSP, shellfish toxin
Do not eat, sell, or serve recalled cucumbers distributed by Fresh Start Produce Sales, Inc. and distributed to certain states. FDA’s investigation is ongoing.
June 5, 2024
The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Salmonella Africana infections potentially linked to cucumbers.
Based on epidemiological information collected by CDC for the Salmonella Africana investigation, as of June 4, 162 people infected with the outbreak strain of Salmonella Africana have been reported from 25 states and the District of Columbia. Of the 65 people interviewed, 47 (72%) reported eating cucumbers.
CDC and FDA are also investigating an outbreak of Salmonella Braenderup infections, with 158 illnesses in 23 states. The two outbreaks share several similarities, including where and when illnesses occurred and the demographics of ill people. Investigators are working to determine whether the two outbreaks could be linked to the same food vehicle. Information will be provided on the source of the Salmonella Braenderup outbreak as it becomes available.
As part of the Salmonella Africana investigation, state partners in the Pennsylvania Department of Agriculture collected samples of cucumbers from several retail locations in their state. One sample supplied by Fresh Start Produce Sales, Inc., of Delray, Florida, tested positive for Salmonella. Additional analysis is ongoing to determine the specific strain of Salmonella that was detected on the cucumbers and if they are linked to an outbreak.
In response to the positive sample, Fresh Start Produce Sales, Inc. has recalled cucumbers grown in Florida. English and mini cucumbers are not included in this recall. Cucumbers distributed by Fresh Start Produce Sales, Inc. are from a variety of growers. The grower that likely supplied potentially contaminated cucumbers is no longer growing and harvesting cucumbers for the season.
The investigations are ongoing to determine the source(s) of contamination and whether these or other products are linked to illnesses. FDA will update this advisory should additional consumer safety information become available.
See CDC Investigation Notice for Case Information for Salmonella Africana and Salmonella Braenderup
Product Distribution*: AL, FL, GA, IL, MD, NC, NJ, NY, OH, PA, SC, TN, VA, WV
*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states.
June 4, 2024
Recall noticesExternal Link Disclaimer have been posted related to JBR’s expanded recall of certain frozen half-shell oysters.
JBR (KR-15-SP) Tongyeong, Republic of Korea (ROK) is voluntarily recalling all frozen half-shell oysters harvested between 11/26/2023 and 2/14/2024 to ensure public health and safety in the U.S. due to the possible contamination with norovirus. The recalled oysters were processed by JBR (KR-15-SP) in Tongyeong, ROK between 11/27/2023 and 2/15/2024 as frozen half-shell oysters and include the following lot numbers: B231126, B231128, B231129, B231130, B231201, B231202, B231204, B231205, B231206, B231209, B231225, B231226, B231227, B240102, B240103, B240104, B240109, B240111, B240114, B240201, B240203, B240204, and B240214.
Retailers should not serve or sell, and consumers should not eat frozen half-shell oysters that were harvested between 11/26/2023 and 2/14/2024, processed by JBR between 11/27/2023 and 2/15/2024, and distributed to restaurants and retailers in Arizona, California, Colorado, Nevada, New Jersey, and Utah. Additional distribution may have occurred, and 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.
Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Food Virus, Food Virus Illness, Norovirus, Norovirus Oysters, Virus
Dairy Manufacturers Inc., of Prosper, TX – 6/3/24, is notifying consumers about a safety issue associated with a product that is an extension of an ongoing voluntary recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-due-non-compliance-requirements-under-21). D-M initiated a voluntary recall on 05/24/24. Crecelac Infant 0-12 with an expiration date of 08/2025 was manufactured at D.M. Mexicana Sa De Cv in Monterey, Mexico and is part of this ongoing recall. D-M is now alerting consumers that a sample of this product has tested positive for Cronobacter spp.
Cronobacter is a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively. Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.
Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.
Crecelac 12.4 oz containers were distributed primarily in March, April, and May of 2024. The product was distributed through retail stores in the state of Texas only. The recalled product is labeled as infant formula and packaged in a 12.4 oz. cardboard and aluminum can.
Only the lot listed below had samples containing Cronobacter spp.
|
PRODUCT |
UPC |
LOT CODE |
EXP. DATE |
|---|---|---|---|
| Crecelac Infant 0-12 | 8 50042 40847 6 | 24 039 1 CHE 352-1 | 08/2025 |
The recalled product can be identified by the batch code on the bottom of the can.
There have been no reports of injuries or adverse reactions due to consumption of these products.
Consumers who have purchased Crecelac Infant 0-12, should discontinue use of the recalled product and return it to the place of purchase for a full refund. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers with questions may contact the company at 1-972-347-2341 (Monday to Friday, 9:30 a.m. to 5 p.m. EST).
This recall is being made with the knowledge of the Food and Drug Administration.
We sincerely apologize for any inconvenience or concern this may cause and assure our customers that we are taking all necessary steps to ensure the safety, quality, and compliance of our products.
Link to Initial Press Release
Posted in Cronobacter sakazakii, FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing
Once Upon a Farm PBC of Berkeley, CA, is recalling Once Upon a Farm Organic Plant-Rich Meal, Curried Carrots & Beans because of potential Listeria monocytogenes contamination.
According to details published online by the Food and Drug Administration (FDA), the recall was initiated May 17, 2024, and is ongoing.
The recalled products were distributed in Tennessee, Georgia, Louisiana, Florida, Alabama, South Carolina, North Carolina, Kentucky, New Jersey and Texas.
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled products and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.
Recalled products:
Once Upon a Farm Organic Plant-Rich Meal, Curried Carrots & Beans, 3.5 oz, packed in single serving flexible pouches.
Consumers should not use this product. Recalled products should be thrown out or returned to their place of purchase.
Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Listeria, Listeria monocytogenes
Products are being sold at some retail stores in Texas and, possibly, additional locations in the U.S.
The U.S. Food and Drug Administration (FDA) is alerting parents and caregivers about Cronobacter safety concerns with Crecelac Infant Powdered Goat Milk Infant Formula and other infant formula products imported and distributed by Dairy Manufacturers Inc. Although the company initiated a recall of the products referenced above on May 24, 2024, because they were not in compliance with all of the FDA’s infant formula regulations, the FDA is now issuing this safety alert due to new findings of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula. As part of its investigation into this matter, on May 29, 2024, the FDA found Cronobacter in a sample of Crecelac Infant Powdered Goat Milk Infant Formula collected from a retail store in Texas.
Separately, the FDA is also alerting parents and caregivers to a recall initiated by Dairy Manufacturers Inc. of the Farmalac products listed above because of their failure to meet U.S. infant formula regulations. Limited sampling of the Farmalac products did not detect Cronobacter; however, the firm has not submitted the required premarket notification to the FDA to demonstrate the safety and nutritional adequacy of the infant formula. The FDA is continuing to work with the firm and its distributors to ensure the recall is effectively executed.
Cronobacter is a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively. Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.
Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.
At this time, the FDA is not aware of any illnesses associated with these products and the FDA does not anticipate any impact on the supply of infant formula based on the recall of these products.
Fresh Start Produce Sales Inc. of Delray, Florida, is recalling whole cucumbers shipped to certain states from May 17th through May 21st, 2024, due to the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The recalled cucumbers were shipped in bulk cartons from May 17th through May 21st, 2024, directly to retail distribution centers, wholesalers, and food service distributors in Alabama, Florida, Georgia, Illinois, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, and West Virginia.
The recalled cucumbers are dark green, approximately 1.5 – 2.0 inches in diameter, and 5-9 inches long. Mini cucumbers and English cucumbers are not included in this recall.
The recall was initiated after the Pennsylvania Department of Agriculture informed the company that a product sample tested positive for the bacteria. The FDA is conducting whole genome sequencing to determine if this sample is related to an ongoing Salmonella outbreak investigation.
CONSUMER ACTIONS:
Although these cucumbers are unlikely in the marketplace, anyone with the recalled product should not consume it and should destroy and discard it or return it to the place of purchase for a refund. Consumers should check with their retailer or place of purchase to determine whether the recalled cucumbers were sold where they shop.
Consumers with additional questions may contact the company at 1-888-364-2993, M-F, 8:00 a.m.—5:00 p.m. EDT.
Fresh Start Produce Sales has notified customers who received the recalled product directly from the company and requested that they remove it from commerce. We have also asked our direct customers to notify their customers of this recall. Fresh Start Produce Sales is issuing this press release and keeping the U.S. Food and Drug Administration (FDA) informed of its recall process to ensure that consumers are properly alerted.
Posted in FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing, Salmonella
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