Drugs

4 Unapproved Homeopathic Injectable Manufacturers Warned

FDA says it has issued Warning Letters to four companies for selling unapproved injectable drug products labeled as homeopathic that the agency says can pose serious risks to patient health and violate federal law. An agency statement says FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic because they are injected directly into the body, often directly into the bloodstream, and bypass some of the body’s key natural defenses against toxins, toxic ingredients, and dangerous organisms that can cause serious and life-threatening harm.

“Additionally,” the statement says, “unapproved drugs that claim to cure, treat, or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.”

Warning Letters were issued to Hervert Pharmaceuticals, MediNatura, Inc., Viatrexx, and Health Advanced Technologies.

The agency statement says that many of the drugs were labeled to contain potentially toxic ingredients such as nux vomica, belladonna, mercurius solubilis, and plumbum aceticum.

Viatrexx was also cited for substandard manufacturing practices for sterile drugs. The foreign manufacturers of the injectable drugs sold by Hervert, MediNatura New Mexico, and Viatrexx were placed on an import alert.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome