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FDA Sends Warning Letter to Teething Tablets Manufacturer

A warning letter from the FDA has cited the CMO that manufactured Hyland’s Teething Tablets for numerous violations.

A warning letter from the U.S. Food & Drug Administration (FDA) has cited the New Jersey CMO that manufactured Hyland’s Teething Tablets for numerous violations ranging from misbranding to inadequate quality testing and procedures.

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?

The letter, issued June 20, 2017, slams Raritan Pharmaceuticals for failing to test the quality of its ingredients and not having manufacturing processes in place that would ensure consistent ingredient levels.

FDA said that when it tested some finished products during a September 2016 inspection, it found excessive levels of belladonna alkaloids in homeopathic products which were sold by CVS and Hyland’s.

Last year, Raritan agreed to halt manufacturing and recall 3 products after intervention by the FDA, but subsequently failed to investigate consumer complaints that its teething tablets may have caused seizures in some children.

The agency said that while many homeopathic products are manufactured without FDA approval, it has the authority to take action when it finds that products fail safety inspection standards.

Belladonna poses little health risk in its diluted form; however, FDA has received hundreds of adverse event reports regarding alleged injuries to children who had been given the products. Some became delirious while others had to be rushed to the hospital after their arms and legs started twitching.

Do I Have a Teething Tablets Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in teething tablet recall lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Case Evaluation: Again, if you’ve been 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.

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