Consumers rely on pharmaceutical manufacturers to produce safe, effective products. Unfortunately, dangerous and defective drugs make their way into the marketplace all the time. In fact, 2014 may be a record year for drug recalls, according to a report released by the Regulatory Affairs Professional Society (RAPS).
The RAPS report tracked drug recalls throughout the year, with 836 recalls occurring within the eight-month time period spanning January to August. More recalls are expected through the end of the year, and the total number for 2014 is likely to surpass the 1,225 drug recalls of 2013. The report also notes that the number of recalls has consistently jumped significantly in the last few years, with just 499 total recalls in 2012.
Jump in Class II Drug Recalls
The majority of the recalls initiated in 2014 involved Class II drug recalls. The Food and Drug Administration (FDA) initiates a Class II drug recall in instances where a drug may cause individuals to experience temporary or reversible side effects or a small chance of experiencing serious side effects.
About Drug Recalls
Drug recalls are designed to protect the public by removing dangerous and defective pharmaceuticals from store and pharmacy shelves after an injury or death has occurred or in cases where dangerous side effects are likely to happen. Drug recalls can occur in a variety of ways, including
- FDA request
- FDA order
- Voluntary recall by the manufacturer
The FDA breaks drug recalls down into three levels, which vary according to the threat posed by a particular drug.
Class I Drug Recalls
A Class I recall is the most urgent type of recall. The FDA issues a Class I recall when a drug is likely to cause immediate or significant danger, including death, to consumers.
Class II Drug Recalls
Class II drug recalls are issued when a drug poses a temporary or reversible threat but is unlikely to cause serious adverse consequences.
Class III Drug Recalls
The lowest level of drug recalls, a Class III drug recall involves no threat to the public. These types of recalls are generally issued when a manufacturer has failed to comply with FDA rules.
Colorado Personal Injury and Wrongful Death Lawyers
Consumers have a right to trust that the medications they take are safe. When this trust is violated, it can lead to serious injuries and even death. The attorneys at the Klibaner Law Firm can help you obtain the compensation you deserve. Call the office today at (303) 863-1445 to speak to an attorney about your case.
This website has been prepared by Klibaner Law Firm for informational purposes only and does not, and is not intended to, constitute legal advice. The information is not provided in the course of an attorney-client relationship and is not intended to substitute for legal advice from an attorney licensed in your jurisdiction.