The U.S. Food & Drug Administration (FDA) has issued a Warning Letter to Raritan Pharmaceuticals, after an inspection of its New Jersey factory turned up shoddy testing and manufacturing processes.
Raritan Pharmaceuticals recalled teething tablets and other homeopathic medications last November, over fears that the products might contain toxic levels of belladonna. This herbal ingredient is used in homeopathic medications for its sedative effect. However, excessive amounts can cause seizures, breathing difficulties and other adverse events in infants and children.
The June 20th FDA letter specifically cites Raritan’s teething tablets.
“You manufacture Infants’ Teething Tablets from ingredients that pose potential toxic effects. Specifically, this drug product contains belladonna and is marketed for vulnerable patient populations, including infants and children under two years of age,” the letter states. “You do not sample and test all components of your homeopathic drug products for conformity with all appropriate written specifications for purity, strength, and quality, or, for components for which a report of analysis is provided by the supplier, in lieu of such testing, you do not conduct at least one specific identity test for such components.”
An FDA Consumer Alert issued last September warned parents and caregivers not to use homeopathic remedies to treat teething pain in infants and children, due to the potential for belladonna poisoning. According to the agency, the products had been implicated in at least 10 infant deaths and hundreds of adverse events, including:
Such symptoms are consistent with belladonna toxicity.
Several retailers responded to the FDA warning by pulling the medications from their stores. Hyland’s Homeopathic stopped U.S. sales of its homeopathic teething tablets and gels, but did not issue any recalls. Raritan Pharmaceuticals agreed to pull several belladonna-containing drugs from the market in November, including CVS Homeopathic Infants’ Teething Tablets, Kids Relief Homeopathic Ear Relief Oral Liquid and CVS Homeopathic Kids’ Ear Relief Liquid.
The FDA issued a warning specific to Hyland’s teething tablets in January. The company finally agreed to recall the medications in April, following a formal request from the agency. However, Hyland’s continued to maintain that the recalled products “met the Company’s safety limit tests and all tested product has been well within an established safety threshold.”
Hyland’s was involved in a similar recall in 2010, after its teething tablets were linked to injuries suggestive of belladonna poisoning.