On May 28, 2020 the U.S. Food and Drug Administration (FDA) issued a Class I recall notice concerning the Medtronic HeartWare Ventricular Assist Device (HVAD) System. A Class I recall is the FDA’s most serious designation and is used only for products that pose a reasonable probability of severe injuries or death. The Medtronic HVAD… Read more »
Acella Pharmaceuticals is recalling 13 lots of NP Thyroid ® – a drug used to treat hypothyroidism – for being “super potent.” According to the recall announcement posted by the U.S. Food and Drug Administration (FDA), the affected lots of NP Thyroid ® contain up to 115 percent of one of the drug’s active ingredients…. Read more »
After discovering the drug for male pattern baldness contained a potentially dangerous ingredient not listed on its label, MasterPharm, LLC. is recalling 1 lot of Finasteride Plus 1.25mg. The affected lot of Finasteride Plus was found to contain minoxidil. Minoxidil is a drug used to treat high blood pressure. According to the recall notice posted… Read more »
Vascular Solutions, Inc. has recalled Langston Dual Lumen Catheters distributed between July 12, 2019 and March 10, 2020 following eight reports that the catheter separated during use. What is the Langston Dual Lumen Catheter used for? The Langston Dual Lumen Catheter is used both to measure blood pressure within a blood vessel and to deliver… Read more »
International Laboratories, LLC has announced that is recalling one lot of its blood thinner drug Clopidogrel due to a serious labeling error. According to the Food and Drug Administration (FDA), some of the drugs in this lot labeled as Clopidogrel Tablets USP 75 mg may actually be a completely different medication – the cholesterol drug Simvastatin. This mislabeling is could result to… Read more »
The FDA announced this week that LeMaitre Vascular, Inc. is recalling over 49,000 of its Over the Wire Embolectomy Catheters that were distributed from November 7, 2014 to March 5, 2020. The LeMaitre Over the Wire Embolectomy Catheter is used to surgically remove either a blood clot, fat, or other material that has lodged in a… Read more »
Recent scientific studies have linked the medication Elmiron to vision-threatening eye damage. Elmiron is a drug that is supposed to treat bladder pain and discomfort from a condition known as interstitial cystitis. Unlike more common pain relievers that are taken as needed when pain arises, this drug must be taken multiple times a day on… Read more »
Surgeons performing heart procedures often rely on what are called “coronary dilatation catheters” to open clogged blood vessels and improve blood flow to the heart. The catheters are supposed to operate by inflating a balloon within the coronary artery. The balloon’s expansion allows a surgeon to place a stent and restores blood flow in a… Read more »
Burg Simpson Shareholders Published in “Trial Magazine” Burg Simpson shareholders Janet Abaray and David Harman were recently published in the January 2020 issue of Trial magazine. In 2019 the U.S. Supreme Court decided Merck Sharp & Dohme Corp. v. Albrecht, which provided clarity on the difficult standard drug makers must meet to prove the affirmative… Read more »
On December 19, 2019, the FDA warned the public of the association between gabapentinoid use and severe breathing difficulties. An FDA evaluation has revealed patients with pre-existing respiratory risk factors who use gabapentin or pregabalin may experience serious breathing difficulties. The respiratory risk factors of concern include old age, lung problems such as chronic obstructive… Read more »
