Two Big FDA Drug and Device Recalls Extend into New Year
FDA drug and medical device officials are continuing their efforts into 2009 with FDA recalls of two dangerous products: the pain patch Duragesic (fentanyl) and a Class I Recall of the ophthalmic medical device Healon D. In both cases, the FDA recall was limited to specific lots of affected, and dangerous, medical products.
The current Duragesic (fentanyl) pain patch recall is on a smaller scope than the previously issued in February 2008 Duragesic recall Tennessee Law Blog had reported. Johnson and Johnson, whose PriCara division’s ALZA Corp produces the fentanyl pain patch, recalled two lots of potentially dangerous Duragesic last week. These recalled dangerous drug patches may contain flaws in the patch that expose users to an immediate and full dosage of the active ingredients, potentially causing trouble breathing and opiate overdose.
Affected by the FDA recall are Duragesic 50 mcg/hr patches in lot number 0817239 as are Sandoz Inc. 50 mcg/hr patches in lot number 0816851.
Last year’s Duragesic recall of nearly 32 million fentanyl Duragesic Pain Patches with the potential to overdose its wearer was initiated not for tears but for excess dosage in the pain patch.
The other major FDA recall, Healon D, which is under a Class I recall (reserved for products that the FDA believes can “cause serious health problems or death”), is due to a chemical agent in the cornea transplant product already linked to optical patients’ eye problems. In addition to cornea transplants, Healon D, an ophthalmic viscosurgical device (OVD), is also used in cataract removal and other ophthalmic procedures.
Manufacturer Advanced Medical Optics has had a Healon recall on lot number UD 30654 in effect since November 2008, but only two-thirds of the recalled product have been returned. The manufacturer has received 66 reports of negative reactions from what appears to be elevated levels of endotoxin (toxins caused by decomposing bacteria) in the drug and of Toxic Anterior Segment Syndrome (TASS), a type of acute inflammation typically occurring within 12–24 hours of cataract surgery.
If you have been injured by a defective medical device or dangerous drug medicine in Tennessee, Georgia, or Kentucky, contact the medical injury lawyers at our Nashville, TN offices by phone (800.705.2121) or by completing a quick prescription drug/medical injury lawyer contact form.
Author Bio
Jim Higgins, founder of the Higgins Firm, is a seasoned personal injury attorney with deep roots in Nashville, Tennessee. A 4th generation Nashvillian, Jim carries on the legal legacy of his father, a judge for over 30 years. After graduating from the University of Memphis School of Law, Jim’s career began on the other side of the courtroom, defending insurance companies and learning their tactics for minimizing settlements. However, he soon realized his true calling was fighting for the rights of the injured, and for the past several years, he has exclusively represented plaintiffs in personal injury cases.
Since then, his dedication and skill have earned him membership in the prestigious Million Dollar Advocates Forum, an organization limited to attorneys who have secured million and multi-million dollar verdicts and settlements for their clients. Licensed to practice in Tennessee, Kentucky, and Georgia, Jim focuses on personal injury, product liability, medical malpractice, and workers’ compensation cases. His exceptional work has been recognized by his peers, earning him a spot on the Super Lawyers list from 2021 to 2024, a distinction awarded to only a select group of accomplished attorneys in each state.
