Florida-based pharmacy Glades Drugs Inc. has recalled compounded multivitamin capsules that the U.S. Food and Drug Administration (FDA) says contain excessive vitamin D. The FDA said this could lead to “severe” health problems in the long term, including heart problems and seizures. The agency said that Glades Drugs has conducted a recall of its multivitamin products in Pahokee, Fla., where it has a recall location. The capsules contain too much of the vitamin D3, or cholecalciferol, which can cause toxic effects without treatment and can be complicated by the fact that symptoms of vitamin D toxicity can take a while to show. The FDA cautioned consumers to stop taking the multivitamins and to consult their doctors. The FDA said in its notice:
Symptoms of short-term vitamin D toxicity are due to high calcium levels (also known as hypercalcemia) and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization and pain.
The FDA’s recall notice on the Glades Drugs products comes at a time of increased scrutiny of dietary supplements by federal agencies. Late last year, seven federal agencies including the FDA and the U.S. Department of Justice (DOJ) announced a number of criminal and civil actions brought against those selling and marketing fraudulent dietary supplements. One of the cases they announced was an 11-count DOJ indictment unsealed earlier in November against USPlabs LLC, S.K. Laboratories Inc. and several of their executives. USP, a Dallas, Texas-based firm, formerly manufactured widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.
Earlier in 2015, state attorneys general drew attention to the labeling of dietary supplements after a study commissioned by the New York state attorney general found that labels for herbal supplements didn’t match their ingredients. The New York and Indiana attorneys general urged the FDA in June to immediately step up its oversight of the dietary supplement industry and strengthen its enforcement, saying that the agency’s dietary supplement current good manufacturing practices regulations need to be reformed.
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