Safety Recall for Product Not Approved by FDA

Dermatend Under Safety Recall Because FDA Did Not Approve Use

safety recallSolace International, manufacturers of Dermatend products which remove moles and warts, has issued a voluntary safety recall after the FDA contacted the company because the product has not been approved for such uses.

The FDA issued a statement regarding Dermatend that moles should only be removed by a dermatologist, and not with a kit at home.

Both Dermatend Original and Dermatend Ultra fall under the safety recall. The products are not FDA approved, and the FDA recommends that consumers immediately stop using the products and consult their physician if they have experienced any warts or changes in moles that have raised concern. Distributors and wholesalers have been asked to return all Dermatend products to the manufacturer as part of the safety recall.

Healthcare professionals whose patients experience side-effects related to these products are encouraged to report the adverse effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Unapproved Drugs and Medical Devices Could Cause Personal Injury

According to the FDA, part of the reason that unapproved drugs continue to be prescribed and used is because many health care providers hear about the drug, and assume it is a generic version of a name brand drug. “Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.   In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs.”

Every year, thousands of consumers sustain serious injuries from defective products. Many of these injuries could be avoided if the manufacturers or distributors of these products took additional steps to ensure consumer safety. If a pharmaceutical manufacturer does not receive FDA approval for a drug or medical device before marketing it, whether or not they have done enough studies, they are putting consumers at serious risk for personal injury.

There are a number of reasons that unapproved and defective products make it to our shelves:

  • Defective manufacturing
  • Inadequate testing
  • Design defects
  • Marketing Misrepresentation

To protect yourself and your family, it’s important to know what products have been recalled because they are defective or unsafe. Federal agencies such as the FDA (Food and Drug Administration) and the CPSC (U.S. Consumer Product Safety Commission) frequently issue recalls for medical devices, drugs, and products that may be harmful to consumers.

The Strom Law Firm Can Help with Personal Injury Cases Against Unappoved Drugs and Devices Like Dermatend

The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, including unapproved drugs. We represent individuals who have been killed or injured by unapproved, dangerous or defective pharmaceuticalsIf you or a family member have been injured or killed after using an unapproved drugs or medical products, contact our drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800

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