A multivitamin sold in the United States has been recalled for containing potentially harmful medications.
OneMultivitaminic GAF-Plus Advance, distributed by Florida-based Armonia Natural Store LLC, has been removed from shelves for containing a steroid (dexamethasone) and a pain reliever (acetaminophen) that are not listed on the product label.
Experts say undeclared ingredients could prove potentially fatal, as they could cause serious side effects when combined with other medications or could trigger adverse reactions in consumers with pre-existing medical conditions.
They say the product could cause a paracetamol overdose, which can cause liver damage and, in severe cases, death.
Meanwhile, corticosteroids taken for “prolonged periods or in high doses, can suppress the adrenal gland” with symptoms including fatigue, weakness, muscle aches, nausea and low blood pressure.
The product also contains sweetener aspartame.
The FDA says it could also be harmful to those who have difficulty metabolizing an amino acid it contains due to a rare genetic disorder called phenylketonuria (PKU).
The label for OneMultivitaminic GAF-Plus Advance does not declare aspartame and “therefore, the product poses a serious health risk to consumers with PKU because its use would result in inadvertent consumption of aspartame.”
OneMultivitaminic GAF-Plus Advance, distributed by Florida-based Armonia Natural Store LLC, has been removed from shelves for medications not listed on the product label.
In total, 64 bottles of the multivitamin, “promoted and sold for pain on various websites, including www.lipoblueadvance.com, and possibly in some retail stores,” have been recalled.
The product, which has an expiration date of ’07/2026′, was distributed in 12 states, including: Florida, Georgia, North Carolina, South Carolina, Rhode Island, New York, New Jersey, Virginia, Nebraska, Illinois, California, and Wisconsin.
DailyMail.com could only find the product on eBay, with one seller advertising it for $24.99 a bottle.
The listing indicates that each bottle contains ten 30 ml servings and consumers are instructed to “shake before use” and take one serving per day.
FDA experts recommend that patients stop taking the compromised multivitamin immediately and “consult your healthcare professional to safely discontinue use of this product.”
The risk level of the recall has been classified as “Class II,” meaning it “may cause temporary or medically reversible adverse health consequences.”
The FDA stipulates that all ingredients must be declared on dietary supplement labels.
It says that if ingredients are not listed in the “Supplement Facts” panel, they should be listed in the “Other Ingredients” list below.
The types of ingredients listed there ‘could include dietary ingredient sources, if not listed in the ‘Supplement Information’ panel (e.g., rose hips as a source of vitamin C), other dietary ingredients (e.g., water and sugar), food additives and colorings.’
Gelatin, starch, stabilizers, preservatives, and flavorings are additional examples of ingredients commonly declared in the “Other Ingredients” list.
The FDA does not test dietary supplements before selling them to consumers, but it does conduct randomized trials.