Medical Malpractice and Personal Injury Law Blog

FDA Announces Recall of Child Medications

Posted by Charles Gilman | Sep 02, 2018 | 0 Comments

According to the FDA, a massive recall of children's medications produced by King Bio is underway. The voluntary recall involves products manufactured from between 2015 and 2018 that may potentially be contaminated. Exposure to various microbial contaminants may result in infections that range from mild to possibly life-threatening. A total of 32 products are subject to this action. King Bio says the problem is likely to exist in a “small percentage” of the products and that no confirmed reports of illnesses or injuries have emerged.

Product Overview

Some of these products include the following:

  • Chicken Pox Relief in 2oz containers designed to alleviate symptoms such as rashes, itching, and blistering
  • Children's Cough medication in 2oz containers
  • A natural Children's Growth & Development product for treating weakened muscles, impaired growth and the inability to properly absorb minerals
  • DK Nosebleed Relief for treating temporary nosebleeds caused by sneezing and coughing
  • The Tummy Aches product in 2oz containers for relief of nausea, cramps and similar irritation experienced after eating
  • Ear Relief Formula in 2oz containers for children with excessive ear wax or other irritation

Distribution Details

The company has alerted consumers and distributors in writing with instructions for return. All distribution and retail have been discontinued. Any users that are experiencing any harmful symptoms are encouraged to see a physician. King Bio has representatives available to answers questions by contacting (866) 298-2740 or via e-mail using [email protected]

Defective Medicine

Prescription and over-the-counter medications are regulated by the FDA, largely to ensure safety; however, defective medications still reach the consumer level and may create significant risks. Often the medication itself is not defective, but errors are found within the product instructions, warnings, or other labeling. The most dangerous labeling mistakes involve failing to include proper warnings regarding the possible dangers that a product may cause.

Class I vs Class II Recalls

Recalls are categorized based on the nature of the problem. Class I recalls are those that involve a “reasonable probability of adverse health consequences”. A Class II recall involves health consequences that are less likely or severe. Some of the common reasons for recalls include:

  • Faulty containers or packaging, particularly involving sterile products
  • A probability of containing mold
  • Labeling mistakes
  • Manufacturing errors such as empty capsules
  • Containing undetermined ingredients or detection of impurities

Product Liability

Those who manufacture, distribute and sell products are susceptible to product liability for defects. The most common varieties of product liability are based on:

  • Defects associated with the manufacturing process
  • Failure in the design of the product
  • Based on failing to warn about defects

Manufacturing problems may stem from using flawed material or insufficient testing and quality control. Some defects in design are not recognized until the products begin to be used by consumers. These claims are often based on general negligence. To prevail in a negligence claim it must be established that the defendant had a duty to care, which was breached and caused the harm incurred. Others are based on strict liability, meaning the defendant may be deemed liable without proving negligence. Claims of product liability may be difficult to prove and be aggressively defended; therefore, those who have been harmed should seek experienced legal counsel.

About the Author

Charles Gilman

As managing partner and co-founder of Gilman & Bedigian, it is my mission to help our clients recover and get their lives back on track. I strongly believe that every person who is injured by a wrongful act deserves compensation, and I will do my utmost to bring recompense to those who need and deserve it.

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