Homeolab USA Receives FDA Warning Letter in Connection with Raritan Teething Tablets Recall

Published on August 16, 2017 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has issued a new Warning Letter to Homeolab USA, in connection with a teething tablets recall announced last year by Raritan Pharmaceuticals, Inc.

“Some of your powder blend mixtures are manufactured from ingredients that pose potentially toxic effects,” the agency said in its August 2^nd letter. “For example, your Infants’ Teething Tablet contains belladonna. Raritan uses this powder blend mixture to produce finished drug products for infants and children, a population vulnerable to the toxic effects of belladonna.”

Raritan received a separate FDA Warning Letter in June, after an agency inspection of its New Jersey factory turned up shoddy testing and manufacturing processes.

This latest letter followed the FDA’s January inspection of Homeolab’s manufacturing facility in Montreal. Among other things, the agency faulted the company for failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength and quality. It also notes that the company had prevented an inspector from taking photographs of excess material clinging to the sides of a piece of manufacturing equipment.

FDA Warns of Teething Tablets Deaths, Injuries

An FDA Consumer Alert issued last September warned parents and caregivers not to use homeopathic remedies to treat teething pain in infants and children, after they had been implicated in 10 infant deaths and hundreds of seizures and other adverse events that may have been related to belladonna poisoning. Belladonna is a common ingredient in homeopathic medications due to its sedative effects. However, exposure to excessive amounts of belladonna can prove toxic.

Several retailers responded to the FDA warning by removing homeopathic teething tables and gels from their stores. Hyland’s Homeopathic stopped marketing its homeopathic teething remedies in the U.S., but did not issue any recalls at that time.

Raritan announced a teething tablets recall in November, after testing indicated that the products might contain toxic levels of belladonna. The recalled products included:

• CVS Homeopathic Infants’ Teething Tablet
• Kids Relief Homeopathic Ear Relief Oral Liquid
• CVS Homeopathic Kids’ Ear Relief Liquid

Hyland’s finally agreed to issue a teething tablets recall in April, following a formal request from the FDA.  However, the company 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.