In a new report published earlier this year, U.S. Centers for Disease Control and Prevention (CDC) data indicates that around 37 million Americans are living with chronic kidney disease (CKD), a condition that gradually damages the kidneys and weakens their ability to clean out waste from the blood.
Like many Americans, patients with chronic kidney disease often turn to dietary supplements for support. The Mayo Clinic estimates that roughly one-third of people with chronic kidney disease use dietary or herbal supplements. But as the U.S. Food and Drug Administration (FDA) points out, talking to and getting approval from a healthcare provider, such as a doctor, pharmacist, or registered dietician, is critical before taking new supplements. Additionally, the agency reminds the public that while they regulate dietary supplements, they do not approve them—a helpful memo in the face of a new recall.
On May 19, the FDA issued a Class II recall of more than 4,000 units of Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, a product of Miami-based company Llorens Pharmaceuticals. According to a product page that may represent the described recalled supplement, it is said to be a “comprehensive kidney support multivitamin.”
The recall affects bottles of B-Complex, Vitamin C & Folic Acid with the following details:
Net weight: 8 fluid ounces (237mL)
Amber PET modern round 24-400 bottle, 47 servings per bottle
Lot number: B202
Expiration date: 8/27
4,196 units
The affected products were distributed to Puerto Rico and 23 states: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Iowa, Indiana, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Tennessee, Texas, Virginia, Washington, West Virginia, and Wisconsin.
The FDA report states that “Foreign object: black particulate matter” as the recall reason, which was initiated by Lloren Pharmaceuticals on May 7. The agency defines a Class II recall as one that may cause temporary or reversible health problems, with a remote chance of serious harm.
The potential foreign or “black” particulate matter was not specified in the FDA report, though the California State Board of Pharmacy alert addressing the recall—in which it refers to the recalled product as “Nephronex”—says that it was due to “the potential intermittent presence of particulate matter associated with the filling process,” and no adverse events had been reported so far.
At the time of publication, Llorens Pharmaceutical had not posted an alert on their website addressing this specific recall.
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