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