Common reasons the FDA issues a product recall

As a previous post discussed, a dangerous or defective product can seriously harm an unsuspecting consumer. Because of that, consumers in Montana and elsewhere should understand the process that helps remove these dangerous products from the market. A recall could be issued, if a product is defective or improperly manufactured.

According to a recent study that focused on the most common reasons the FDA issues a product recall for prescriptions and non-prescription products, there are five major reasons that could trigger the FDA to issue a recall. These include contamination, defects, mislabeling, adverse reaction and incorrect potency.

This study was conducted over a 30-day period, and during that time frame, a total of 21,120 recalled products were identified. Of those, 3,045 met the inclusion criteria.

Based on the findings of this study, there was a significant association found between FDA classification and the reasons issued for recall, product availability, the type of the recall firm and the form of communication used. Researchers involved in this study also found that compounding facilities were commonly linked to contaminations leading to recalls.

When a prescription or non-prescription product is contaminated, deemed defective, is mislabeled, causes adverse reaction or was sold with an incorrect potency, these could cause serious and harmful effects to a consumer. If these items are not properly or timely recalled, a dangerous product could seriously injure or even cause the death of a consumer.

Because severe effects could result, it is important that defective or dangerous products are removed from the market. While there are processes that help reduce the number of dangerous products in the market, this, unfortunately, does not protect all consumers from these products.

Those harmed by a defective product should take the time to understand the recourses available to them. A products liability claim could help an injured consumer recover compensation for the losses and damages incurred by a dangerous product.


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