Atlanta Products Liability Attorneys Explain Voluntary Recall of Over-the-Counter Medications


June 14, 2018

The product liability lawyers at Montlick & Associates, Attorneys at Law, maintain a close watch over the recalls for over-the-counter medications and medical products announced by the U.S. Food and Drug Administration (FDA). The FDA issues recalls after receiving information from consumers, healthcare providers, or the drug manufacturers themselves that the product could harm someone who used it. 

The authority to recall drugs is a pivotal function the FDA provides consumers. Without it, many people would never know that the products they find on the shelves of the local markets, pharmacies, and superstores might seriously harm them. The FDA approves medical products before those goods hit the shelves. However, there are many occasions when the FDA approved a product as being safe, only to learn after the consuming public used it, that the medication or medical device was defective or dangerous. 

Montlick & Associates, Attorneys at Law, have distinguished themselves from other Georgia law firms by their tenacity, their skill, and the dedication to their clients. Montlick & Associates product injury lawyers understand the challenges a victim of a defective product faces recovering from injury, getting back to work, and adapting to their new lives after their injury. 

FDA’s Recall Function

The FDA’s recall authority over consumer medical products is aptly illustrated by a recall notice issued by the FDA on January 29, 2018. The FDA announced the recall in cooperation with Kareway Products, Inc. Kareway Products, Inc learned that their Gericare Eye Wash Sterile Eye Irrigation Solution was not sterile after all. Consequently, Kareway decided to recall 60,000 units of the product. Kareway sold the Gericare Eye Wash to hospitals, doctors’ offices, and pharmacies. 

Neither Kareway nor the FDA specifically explained how bacteria got into the solution or how they learned about the problem. The FDA noted in its press release that Kareway had not received any reports of injuries or illnesses from a defective bottle of Gericare solution. 

Notwithstanding the lack of injuries, the FDA described the potential for injury from using the contaminated solution as “calamitous.” Calamitous is a very strong word. The FDA is justified using “calamitous” when describing the “probability” of losing one’s eyesight permanently to an eye infection from using the infected solution.

False or Misleading Labeling Could Lead to Legal Liability

Products liability law in Georgia prohibits medical product and drug manufacturers from using false or misleading labeling on their products. All manufacturers of consumer goods have an obligation to warn their customers about the possibility of harmful or dangerous side effects. The FDA requires manufacturers to publish any potential problems on the product’s labels. The manufacturers typically derive the possible side effects from trial periods before the FDA approves the product for sale. Many dangerous or deadly side effects do not surface until people use them for a long time. 

The FDA recognizes, however, that some warnings must be more prominent than others. Accordingly, the FDA mandates drug manufacturers to place a “Black Box Warning” on their labeling so that the attention of doctors, physicians, and consumers is called to the possible dangers of consuming the medication are expressly set out from the “fine print” on the medication label.

Put Our Law Firm's Over 34 Years Of Legal Experience To Work For Your Case!

If you have been injured in any type of accident caused by someone else’s negligence, call Montlick & Associates, Attorneys at Law for your free consultation today. Montlick & Associates, Attorneys at Law has been representing those who suffer serious injuries throughout all of Georgia and in the Southeast for over thirty-four years, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. 

No matter where you are locatedour attorneys are just a phone call away, and we will even come to you. Call us 24 hours day/7 daysa week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour live chat. 

Sources: cited within

Category: Personal Injury

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Many of our blog articles discuss the law. All information provided about the law is very general in nature and should not be relied upon as legal advice. Every situation is different, and should be analyzed by a lawyer who can provide individualized advice based on the facts involved in your unique situation, and a consideration of all of the nuances of the statutes and case law that apply at the time.