The FDA has sent a warning letter to a New York-based homeopathic medication maker, marking the third warning in as many months that the FDA has sent to makers of the natural products.
The FDA last week issued a warning letter to the HomeoCare Laboratories facility in Yonkers. The letter made clear that while the plant’s products are labeled homeopathic, they still have to meet certain FDA standards and that inspectors had found shortcomings in the processes that would ensure that.
The FDA criticized the facility for not having processes to make sure that the ingredients it uses, including some that can be toxic like strychnine, meet standards for identity, strength, quality, purity and potency. Among other problems, it found that the company did little in-process testing and and generally only tested finished products for microbiological contamination, so couldn’t be certain of uniformity.
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That latest FDA action came a month after the FDA sent a warning letter to a Homeolab USA facility in Montreal, Québec, which in turn, came weeks after it sent a warning letter to Raritan Pharmaceuticals, a New Jersey CMO that provides contract manufacturing services for Homeolab USA.
And those two warning letters arose after the FDA became concerned of reports of about potential adverse effects in children who used homepathic belladonna-treated teething products.
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The FDA last issued a consumer alert warning to parents to dispose of homeopathic teething tablets and gels because they posed a potential risk.
It said consumers should seek medical care immediately if their child experienced seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using homeopathic teething tablets or gels.