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FDA Announces Recall Of More Than 30 Kids & Infant Medicines — Here's What You Need To Know

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Homeopathic medicine company King Bio is voluntarily recalling 32 various children and infant medications due to a microbial contamination. The U.S. Food & Drug Administration (FDA) announced the recall on its website on Wednesday, along with details about the contamination and a list of the affected medicines.

According to the FDA's announcement, a recent test of King Bio's medications revealed that a "small percentage" (no official numbers were disclosed) of products made between August 2017 and April 2018 tested positive for microbial contamination. A microbial contamination is when microbes like "bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins and by-products" infect something, according to the Journal of Pharmaceutical Microbiology.

The FDA explained that taking a medication with microbial contamination could cause infections of varying severity, which could be life threatening. Luckily, no one has reported any infections due to any of the recalled King Bio medications.

If your child has taken any of the 32 recalled medications and had no adverse reaction, the FDA says there is likely nothing to worry about. However, if your child did have a bad reaction to any of the recalled products, the FDA recommends consulting with a doctor. Additionally, you can report any issues with the medication to the FDA's MedWatch Adverse Event Reporting program. Most importantly, the FDA says customers should discontinue use of the recalled medications, even if they have taken the product and had no adverse reaction.

The 32 recalled medications are:

  • DK Attention & Learning Enh.
  • Chicken Pox Symptom Relief
  • Children's Appetite & Weight
  • Children's Appetite Enhance
  • Children's Cough Relief
  • Children's Fever Reliever
  • Children's Growth & Development
  • DK Newborn Tonic
  • DK Nosebleed Relief
  • TonsilPlex
  • Children's Ear Relief Formula
  • DK Teething
  • DK Colic Relief
  • Tummy Aches
  • Kids Multi-Strain Flu Relief
  • Kids Stress & Anxiety
  • Kids Sleep Aid
  • Kids Bed Wetting (NP)
  • Kids Candida 4 oz
  • Kids Attention & Learning (SCRX)
  • Bed Wetting Prevention (SCRX)
  • Chicken Pox Symptom Relief (SCRX)
  • Children's Cough (SCRX)
  • Children’s Ear Formula (SCRX)
  • Children’s Fever Reliever (SCRX)
  • Children’s Growth & Development (SCRX)
  • Colic Relief (SCRX)
  • Newborn Tonic (SCRX)
  • Teething (SCRX)
  • Tummy Aches (SCRX)
  • Children’s Appetite & Weight (SCRX)
  • Children’s Appetite Enhancer (SCRX)

The 13 medications labeled as SCRX are sold under the brand name SafeCare RX, and those products are only used by healthcare providers, Fox 8 reported.

Romper corresponded with a spokesperson for King Bio, who clarified that only two of the 32 products were potentially contaminated. "Only two of our children’s products tested positive for microbial contamination, one lot of Bed Wetting, and one lot of Teething," the spokesperson explained. Dr. Frank King, the founder and president of King Bio, further explained why the company chose to recall all of the listed 32 products that were produced in the last three years. In a statement sent to Romper, Dr. King said:

As a company dedicated to the mission of producing safe medicine, and out of an abundance of caution, we have chosen to go far beyond a traditional voluntary recall of only the few implicated products. Even though no injury or harm has ever been reported by anyone regarding our products, we voluntarily chose to go the extra miles of recalling all of our children’s products. We hope our extensive action of caution proves to all our deep commitment to safe, natural and pure medicines.

If your child has taken any of these medications, visit the FDA's recall announcement for more detailed information on the products' lot numbers. For any questions about the recall, King Bio can be contacted at (866) 298-2740 or at recall@kingbio.com. Additionally, King Bio plans to mail letters to customers to offer returns and replacements for each of the recalled medications. However, if you did not buy the product directly from King Bio, it seems unlikely the company will have your address, so you can go ahead and contact the company on your own for a refund.

This is not the first time King Bio has issued a medication recall. Last month, King Bio voluntarily recalled three products due to a microbial contamination, the Atlanta Journal-Constitution reported. The recalled products were the Aquaflora Candida HP9 8 oz. liquid in a carton, King Bio Lymph Detox 2 oz. liquid in a carton, and King Bio Baby Teething 2 oz. liquid in a carton, according to the FDA's announcement at the time. The FDA discovered that the contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens, and Burkholderia Multivorans were present in the three medications while conducting a routine investigation.

Even though a microbial contamination sounds scary, it's definitely a good sign that no one has reported any sort of infection or illness due to taking the recalled medications.