Endo Health Solutions, Inc.

So far this year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.While neither recall has resulted in any safety flags or side effect reports so far, the issues stemming from the faulty products could be severe, the drugmakers have warned.First up, German drug and devicemaker B. Braun Medical is yanking two lots of injectable 0.9% sodium chloride to the consumer level in the U.S. The company blamed the product pull on the potential for particulate matter and fluid leakage from the product’s “E3 containers.” The solution is used in both kids and adults as a source of electrolytes and water for hydration. The product is specifically approved for extracellular fluid replacement, treatment of metabolic alkalosis with fluid loss and mild sodium depletion. The product is also used as a priming solution for hemodialysis procedures and may be used to kick-start and terminate blood transfusions without hemolyzing red blood cells.The German firm says it mistakenly released the affected batches to domestic distributors across the U.S. before completing required acceptance activities for embedded particulate matter.While the company hadn’t received any safety reports as of Aug. 8, there is a risk of patients suffering embolic issues like stroke or ischemia/infarction to other organs, plus possible infection, if the particulates in the product aren’t sterile, B. Braun warned.Separately, Baxter International is voluntarily withdrawing a single lot of heparin sodium in 0.9% sodium chloride injection due to the potential for elevated endotoxin levels.The injection is used as an anticoagulant to maintain catheter patency—or the state of being open or unobstructed. Baxter says it shipped the suspect batch to U.S. healthcare facilities, wholesalers and distributors between March 12 and Aug. 24.Using heparin with excess endotoxin levels could lead to serious health consequences for patients such as toxic shock, organ failure and death, the company warned.As of Aug. 6, the company hadn’t received any adverse event reports tied to the product pull.Over the last year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. Most recently, Endo USA—a unit of Endo Pharmaceuticals—recalled a single lot of clonazepam tablets in July thanks to a labeling issue that resulted in an incorrect strength being printed on the product cartons.Endo blamed the issue on a third-party packager.As for the risk of particulate matter turning up in drugs, Pfizer’s Hospira in October recalled three lots of sodium bicarbonate and lidocaine HCI injectables due to the possible presence of glass particles in vials. 

SOUTHFIELD, Mich., July 18, 2024 /PRNewswire/ -- MASSIVE: Medical and Subrogation Specialists have been selected by the Personal Injury Trustee and Claims Administrator to be the exclusive Lien Resolution Administrator for the Endo Opioid Bankruptcy Trust. MASSIVE has a wide range of experience working on Mass Tort projects and was also selected as the exclusive lien resolution administrator in the Just for Men hair dye, Mallinckrodt Opioid Bankruptcy Trust, Purdue Opioid Bankruptcy Trust, Cordis IVC filter, and as the Flint Water case co-lien resolution administrator. Continue Reading "MASSIVE is excited to, once again, help those harmed by the Opioid crisis." Ryan Weiner, Esq., Partner at MASSIVE Post this "MASSIVE is excited to, once again, help those harmed by the Opioid crisis," says Ryan Weiner, Esq., Partner at MASSIVE. "We will work with enthusiasm and diligence to reduce lien holders' claims against each claimant's settlement award." In early 2024, Endo Health Solutions Inc. agreed to resolve both criminal and civil investigations for their role in the opioid epidemic. MASSIVE expects to resolve liens for more than 30,000 injured claimants. We are eager to help these victims maintain their settlement dollars. ABOUT MASSIVE MASSIVE: Medical and Subrogation Specialists is a nationwide provider of healthcare lien resolution services. By working hand in hand with personal injury law firms across the nation in both Single Event and Mass Tort cases, MASSIVE expedites settlements through cutting-edge software, services, and support. SOURCE MASSIVE: Medical and Subrogation Specialists

Endo Pharmaceuticals' unit Endo USA has issued a voluntary recall of one lot of the anti-anxiety drug clonazepam. Endo USA, a unit of Endo Pharmaceuticals, issued a voluntary recall of one lot of clonazepam tablets due to a labeling issue that resulted in an incorrect strength being printed on the cartons. The recall affects 0.25 milligram tablets with labeling that wrongly indicates they were 0.125 milligrams in strength, the company said in a July 16 press release. Despite the error, the blister pack featured the correct strength description. The company said the error was due to a third-party packager. Clonazepam is typically used for acute treatment of panic disorder, epilepsy, and nonconvulsive status epilepticus. It is also used for off-label treatment of restless leg syndrome, acute mania, insomnia, and tardive dyskinesia. The recalled lot was packaged in cartons of 60 tablets with a National Drug Code (NDC) number 49884-307-02. The drugs were distributed nationwide through wholesale distributors to retail pharmacies, which are being asked to return any existing inventory they have. Endo warned that there is a “reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.” To date, Endo hasn’t received any reports of adverse events associated with the recall, the company said. The latest voluntary recall falls just four months after another Endo unit, Par Pharmaceutical, recalled one lot of its pulmonary arterial hypertension (PAH) drug treprostinil injection from the U.S. market over concerns that silicone particles could be in vials of the drug. Treprostinil is a generic to United Therapeutics’ Remodulin, which has been marketed for over 20 years. In February, the parent company Endo, agreed to pay a bankruptcy settlement worth up to $464.9 million to the federal government after a Department of Justice investigation into its previous marketing of opioid painkiller Opana ER.