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Recalls That Should Be on Your Radar—Week of May 12, 2019

MAY 18, 2019 | CONTAGION® EDITORIAL STAFF
We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Novartis Issues Recall of Promacta 12.5mg for Oral Suspension Due to Potential Contamination

Novartis today announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.

Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.

Peanut is a known food allergen. Potential cross contamination with peanut flour, even in small traces, can lead to hypersensitivity reaction in a population of patients with an unknown or known sensitivity to peanut antigen, including a medically significant anaphylactic reaction, which can be fatal.

Read about this recall here.

Seven Seas International USA, LLC Issues Recall of Biltmore Salmon Due to Potential Listeria Contamination

Seven Seas International USA, LLC of St. Petersburg, Florida is recalling its 4 oz. Biltmore Smoked Sockeye Salmon, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The 4 oz. Biltmore Smoked Sockeye Salmon was distributed only in Florida by Publix Grocery stores. The product can be identified by its production code, which is a four digit code printed on the clear vacuum bag that contains the product. The Biltmore Smoked Sockeye product is sold in 4 oz. black printed carton sleeves with the Brand name “Biltmore” printed on the front, containing the smoked sockeye product in a clear vacuum bag, the product is displayed on a gold plate. Only products with Production Code 41CM and a sell by date of 23rd May 2019 are subject to this recall, all other production codes are not part of this recall. The product carries the following UPC code: 007-36211-88774
No illnesses have been reported to date.

Read more about this recall.

Crab House Trading Corp. Issues Recall for Siluformes Without Benefit of Inspection

Crab House Trading Corp., a Los Angeles, Calif. establishment, is recalling approximately 36,040 pounds of frozen Siluriformes products, specifically yellow walking fish, that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

These items were shipped to retail and wholesale locations in California. The problem was discovered by FSIS during follow-up surveillance activities.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a health care provider.  

FSIS is concerned that some product may be in consumers’ freezers. 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.

Read more about this recall here.

Ethicon Recalls Circular Staplers for Product Defects

Through investigation of complaints and returned products, Ethicon confirmed uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure.

In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.

The use of affected product may cause serious patient harm or death. Ethicon confirmed serious injuries to two patients. Misfiring of the stapler resulted in an additional resection -- of the middle rectum in one patient and the lower rectum in another patient -- during the planned resection of the upper rectum. Potential risks to patients include death, sepsis, bleeding, the need for permanent ostomy "bag," life-long nutritional and digestive issues, leak in the closure (anastomotic leak), additional surgeries, need for additional closures (anastomoses), need for antibiotics, and the need for additional imaging studies.

Read more about this recall here.

Broddzenatti Holding LLC Issues Recall for Tahini Linked with Salmonella

Broddzenatti Holding LLC of Jupiter, Florida is recalling retail and bulk Karawan brand Tahini, sold in 16-ounce jars and 39-pound buckets that were imported from Palestine between the dates of December 2018 to January 2019, because it has the potential to be contaminated with Salmonella, an organism which 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.

Karawan brand Tahini was distributed in the following states: New York, Massachusetts, Virginia, and Texas and distributors sold the product to retail stores.

Read more about this recall here.
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