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Pharmaceuticals / Inspections and Audits

Homeopathic Drugmaker Violated Production Standards, FDA Says

Sept. 18, 2017

A New York maker of homeopathic medicines that include toxic ingredients ran afoul of the FDA because it made drug-like claims for its products but did not manufacture them to the standards invoked by the claims, the agency said in a warning letter.

HomeoCare Laboratories said its HBP Relief “relieves symptoms associated with high blood pressure (hypertension)” and that its IBS Relief “gently helps correct a dysfunctional digestive system,” the letter said.

The company also violated current good manufacturing practices by failing to: establish written procedures for production, follow adequate procedures for in-process testing of production batches, test and validate incoming supplies, and perform annual reviews of the quality of its products.

HomeoCare also failed to test for strychnine in a tincture that can contain the toxin, the agency said.

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