November 27, 2020

Don’t Use Maison Terre Goldenseal Root Powder, FDA Says

The FDA is telling health care professionals and consumers to not use a product called Maison Terre Goldenseal Root Powder, because it is contaminated with high counts of various bacteria, including "multiple pathogens," according to a government press release. The company that repackaged and distributed this product, Maison Terre, is located in Little Rock, Arkansas. Goldenseal root powder has been used in various ways as a herbal supplement. It can be made into a tea, or ingested if sold in tablet or capsule form. It also may be applied to the skin as a topical treatment. Some people use it for indigestion and heartburn, and it has been used as a mouthwash to help heal canker sores. FDA laboratory analysis discovered the contamination. The advisory states, "Use of these … [Read more...]

FDA Warns Consumers About Adverse Events Associated with Limbrel, a Dietary Supplement

The FDA is alerting consumers about "potentially life-threatening health problems" linked to Limbrel, a dietary supplement that is marketed to "manage the metabolic processes associated with osteoarthritis." The company is not removing the product from the market. This product is marketed as a medical food, but the FDA's investigation determined that it is an unapproved new drug. And the FDA does not have mandatory recall authority over drug products. The FDA is reminding consumers "not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise … [Read more...]

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