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A snack produced by an Oregon-based firm that was recalled earlier this summer has now been issued a risk classification by the U.S. Food and Drug Administration (FDA).
Orwaiian LLC, based in Gresham, issued a recall in August for its Bday Crunch Mochi Crunch snack because of undeclared milk and coconut in the product’s “contains statement.” All the allergens were included in the product’s ingredient statement.
The recall, initiated on August 21, impacted 720 units distributed in California, Oregon, Washington, Washington D.C. and Hawaii.
The affected batches had expiry dates of 07/29/2025 or earlier, and are identified by the UPC code 7189147148, and the MFG code MCBD05.
The FDA has now issued a Class II risk classification for the recall as of September 11.
A Class II recall is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Orwaiian LLC told Newsweek: “We are working with FDA and ODA (Oregon Department of Agriculture) to ensure we are following the appropriate steps. All retail consignees have been sent a recall notification letter.
“We are working on improving our process by further reviewing our labels utilizing internal and third-party reviewers following FDA guidelines and requirements.”
The Oregon Department of Agriculture added: “People who have an allergy or severe sensitivity to milk and/or coconut run the risk of serious or life-threatening allergic reaction if they consume this product.
“Customers who may have purchased the above product between May 18th 2023 and up to July 29th 2024 are urged to destroy them or return them to the place of purchase if you are sensitive to milk and/or coconut.”
Milk is one of nine “major food allergens” as defined in legislation, and cross-contamination can trigger the potentially deadly condition of anaphylaxis in those with a milk allergy.
The other major allergens include eggs, fish, crustacean shellfish (for example crab, lobster, and shrimp), tree nuts (including coconuts, almonds, and walnuts), peanuts, wheat, soybeans and sesame.
Anaphylaxis requires immediate medical attention and can lead to constricted airways in the lungs, severe lowering of blood pressure and shock, and suffocation by swelling of the throat and larynx.
Other symptoms of serious allergic reactions include hives; flushed skin or rashes; a tingling or itchy sensation in the mouth; face, tongue or lip swelling; vomiting and diarrhea; abdominal cramps; coughing or wheezing; dizziness or lightheadedness; swelling of the throat and vocal cords; difficulty breathing; and loss of consciousness.
About 6.2 percent of U.S. adults have at least one food allergy, according to the National Center for Health Statistics.
In addition to allergy concerns, milk poses a risk for people with lactose intolerance, which is the inability to properly digest a type of sugar that is present in dairy products.
Symptoms of lactose intolerance include bloating, diarrhea, gas, nausea and abdominal pain, according to the National Institutes of Health. The condition can also lead to long-term adverse health effects by blocking the absorption of calcium and vitamin D.