Actavis recalled 18 defective lots of its Fentanyl Transdermal System 25 mcg/hour C-II patches used to treat chronic pain due to possible injury of active ingredients being released too fast. This latest recall of over one million units is only one of many – which many say only confirms that the company continues to have serious issues when it comes to safety and quality control.
Actavis Fentanyl Transdermal Patch Recall
New Jersey based Actavis Inc. has recalled the following lots of its Fentanyl Transdermal System 25 mcg/hour C-II patches with these lot numbers and expiration dates:
According to the U.S. Food & Drug Administration (FDA), Corium International Inc. – a third-party supplier for Actavis --identified one lot of 25 mcg/hour Fentanyl patches (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient in laboratory testing faster than the approved specification.
The FDA says that an accelerated release of Fentanyl from a 25 mcg/hour patch could lead to adverse events for at-risk patients such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). Unfortunately, this is not the first time Actavis has shipped out defective products.
Same issue, different day...
The company issued a similar recall in 2008 and has consistently been in trouble with the U.S. Food & Drug Administration (FDA) over safety and quality control issues. In fact, the company entered into a consent decree with the FDA last year which covered all drugs produced at its Totowa facilities in New Jersey and requires the company to retain outside experts to ensure compliance with the FDA's good manufacturing practices (cGMPs).
A Pattern Of Negligence
The company also recalled its heart drug, Digitek, because some of the drugs distributed had double the normal potency – a serious mistake that simply should never happen.
Consumers injured by defective drugs may be entitled to compensation for their injuries including lost wages, pain and suffering and medical bills. An experienced drug litigation lawyer can evaluate your situation so that you can determine whether filing a product liability lawsuit may be right for you.