The U.S. Food & Drug Administration (FDA) has issued a warning letter to Raritan Pharmaceuticals, the company that manufactures Hyland’s teething tablets that were recalled for inconsistent belladonna levels, after an inspection found quality testing and misbranding violations.
Free Confidential Lawsuit Evaluation: If your child or other loved one was harmed by teething tablets, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the problem?
June 27, 2017 – FDA’s warning letter was issued in response to violations found during an inspection of Raritan’s East Brunswick, New Jersey, facility conducted between Sept. 29 and Oct. 20, 2016. The violations ranged from misbranding to inadequate quality testing and procedures, according to FiercePharma.
According to the warning letter, Raritan failed to test samples of components for identity and conformity with quality specifications.
After sampling product lots, FDA inspectors found “that the material was not homogenous in composition and exhibited high variability, which render it of unacceptable quality,” the letter said. “Because the component was not of uniform character and quality, it should not have been released for use in the manufacture of drug products. This variability exposes infants and children who are given your drugs to potentially significant safety hazards from belladonna levels far beyond the labeled content.”
Batch failure investigation was also not adequately performed, according to the FDA. Complete analysis of customer complaints was not documented and specific investigations were not conducted.
FDA also cited Raritan for misbranding of drug products. The letter stated that while the company labels its products as homeopathic, they are still subject to the same regulations as other drugs.
“Under section 502(a) of the FD&C Act [21 U.S.C. 352(a)], a drug is misbranded if its labeling is false or misleading in any particular,” the letter said. “FDA’s test results on samples of ‘Homeopathic Infant’s Teething Tablets’ indicate alkaloid content that widely varies from the content stated on the product labeling, including alkaloid content that far exceeded the labeled claim of alkaloids for ‘Homeopathic Infant’s Teething Tablets.’”
Do I Have a Teething Tablets Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in teething tablets lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if your child was injured by belladonna toxicity, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.