The potential for allergic reactions to the presence of undeclared milk led Pure Solutions of Tampa, Florida, to withdraw its Pure Factors Professional Nighttime Sleep Formula.
The enforcement report states that the voluntary recall applies to individual one-fluid-ounce glass bottles of the liquid dietary supplement. The bottles are fitted with dropper caps and have an expiration date of May 2028.
According to the report, the “label declares bovine colostrum but does not declare milk allergen.”
The sleep aid was distributed in 36 states, comprising Arkansas, Florida, Colorado, California, Connecticut, Hawaii, Indiana, Illinois, Idaho, Iowa, Kansas, Kentucky, Louisiana, Ohio, Oklahoma, Oregon, Massachusetts, Michigan, Minnesota, Missouri, Georgia, North Carolina, Nebraska, North Dakota, New York, Pennsylvania, South Carolina, Tennessee, New Jersey, Utah, Texas, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
There are nine major food allergens that the FDA requires all companies to identify in their products, as some individuals are allergic to them.
They comprise milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
The study found that undeclared milk makes up 37.5 percent of recall events, followed by soy at 22.5 percent, and tree nuts at 21.6 percent.
Similar Recalls
In a separate but similar milk allergen recall, B.C. Williams Bakery Service of Dallas, Texas, withdrew 866 bags of its Spice Cake Mix, Bread and Roll Mix, and Swiss Chocolate Cake Mix.A Class 1 event is defined by the FDA as having a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
When someone with a milk allergy consumes dairy products, their immune system mistakes milk proteins as harmful invaders, and launches an attack that can trigger symptoms within minutes.
The reactions can range from mild discomfort to life-threatening symptoms.
Mild symptoms of allergic reactions include hives, an itchy mouth, watery eyes, and stomach cramps. More severe cases can cause vomiting, difficulty breathing, and swelling of the lips, tongue, or throat.
In the most serious situations, a milk allergy can cause anaphylaxis. According to the Mayo Clinic, anaphylaxis can result in a fatal narrowing or blockage of the airways.