Use of Drug Leads to Baby Medicine Recall

Last month, as you may recall, the Food and Drug Administration (FDA) issued an advisory regarding the use of several homeopathic teething products and some were pulled from the market. According to the FDA advisory, the agency recommended that parents and caregivers refrain from administering certain homeopathic teething tablets and gels to children and to instead seek advice from their health care professional for safer alternatives.

Now, just before the Thanksgiving holiday weekend, Raritan Pharmaceuticals issued a voluntary recall for several over-the-counter homeopathic children’s drugs. In particular, they have recalled:

  • CVS Homeopathic Infants’ Teething Tablets, 135 tablet size with UPC 050428424162 and lot codes 41116 and 43436. (Note that CVS pulled this product from their shelves previously and asked consumers to return them on September 30, 2016);
  • Kids Relief Homeopathic Ear Relief Oral Liquid, 0.85 fl. oz., with UPC 778159090639 and lot code 35254;
  • CVS Homeopathic Kids Ear Relief Liquid, 0.85 fl. oz. with UPC 050428441633 and lot code 33149

The recall was issued after the FDA conducted a number of tests that verified an inconsistent level of belladonna in the products that did not match what is shown on the labels. The test were conducted because of concern over the potential danger of inconsistent dosages of belladonna in the products.

The FDA conducted tests on the varying levels of belladonna extract from Raritan Pharmaceuticals products to compare the amount declared on the labels. Because of the potential danger of inconsistent doses of belladonna in the products. According to experts, belladonna, which means “beautiful lady” in Italian, was once used by Italian women to enlarge their pupils, which they believed gave them a more striking appearance. However, belladonna contains atropine, which can be somewhat poisonous in large doses. Atropine can be fatal to adults in doses of 100 mg, but it can be even more dangerous for small children, so belladonna should not be used unless prescribed by medical professionals.

Though precautions have been taken to limit the use of belladonna, it is still used to treat Parkinson’s disease, colic and motion sickness and it is sometimes used as a sedative to relieve bronchial spasms. It is also considered a pain remedy and it is commonly an ingredient in ointments used to treat joint pain. Raritan Pharmaceuticals is those who are currently taking the drugs to stop and contact them for more information about the recall. The FDA is also asking those consumers who have used the products to report any adverse reactions or quality problems to FDA’s MedWatch Adverse Event Reporting program.

Parents with small children naturally wish to protect them from all potential risks. In this case, if a doctor doesn’t prescribe this product and supervise its use, it’s probably not worth the risk. The manufacturers and sellers of baby products have a responsibility to make their products as safe as possible. If your child has become sick after using this or any other a product made for young children, take them to a doctor first. If they are diagnosed with an illness and it is linked to this or any other defective product, please contact the Defective Baby Products Lawyer at Hill Law Firm as soon as possible, so that we can conduct a thorough investigation and make things right for you and your child. We have the knowledge and experience to take on any company and make them take responsibility.

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