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Posted June 16, 2020

FDA Warns Four Companies for Unsafe "Homeopathic" Injectables

On June 16, 2020, the FDA issued warning letters to four manufacturers of unapproved injectable drugs labeled as homeopathic. The FDA has warned against injectable herbal products and drugs before but stated that unapproved injectable drug products labeled as homeopathic are particularly dangerous 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."

Some of the products injectable homeopathic products contain ingredients such as belladonna, "Nux Vomica" (contains strychnine) and "Lachesis Mutus (venum [sic] of the bushmaster snake)."

The four companies that received a warning letter for manufacturing violations including unapproved injectable drug products are as follows (use the links below to read the full warning letter):
  • Hevert Pharmaceuticals LLC USA (Arnica, Calmvalera comp., Gelsemium comp., Hepar comp., and Lymphaden comp)

  • Medinatura Inc (Zeel Injection Solution, Traumeel Injection Solution, Engystol Injection Solution, Neuralgo Rheum Injection Solution, Lymphomyosot X Injection Solution, and Spascupreel Injection Solution)

  • 8046255 Canada Inc. DBA Viatrexx (Articula, Mesenchyme, Connectissue, MuSkel-Neural, Ouch, Ithurts, Adipose, Systemic Detox, Hair, Neuro 3, Infla, Collagen, Prolo, Lymph 1, GI, Neuro, Arthros, Male+, Immunexx, Relief+, Intra-Cell, Facial, and ANS/CNS)

  • World Health Advanced Technologies Ltd (Enercel AM, Enercel Forte, Enercel Max, Enercel Mist-Nasal, Enercel Mist Nebulizer, Enercel PM, Vanicel, Enercel Plus, and Enercel Plus IM)

The products were promoted with statements such as "for the treatment of muscle pain and stiffness, bruising and swelling due to injuries and overexertion," "a homeopathic drug product indicated for the treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness," and "injected into the various layers of the skin, muscles, ligaments or other body tissues where collagen support or regeneration is desired."

In 2017, a woman died after receiving an IV infusion of turmeric.

See related warnings:

Injectable Curcumin, CBD Are Not Safe, Warns FDA

FDA Testing Confirms Elevated Levels of Belladonna in Some Homeopathic Teething Products

Woman Dies After Receiving Turmeric Infusion

BIOTA Biosciences Recalls Injectable CBD and Curcumin Products

For more information, use the link below: