Merck Voluntarily Recalls All Lots of LIPTRUZET in the US From Wholesalers Due to Packaging Defects
Merck, known as MSD outside the US and Canada, is voluntarily recalling all lots of LIPTRUZET (ezetimibe and atorvastatin) 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg tablets in the US, including Puerto Rico, due to packaging defects.
Merck is recalling from wholesalers all lots of LIPTRUZET that have been distributed since the product was introduced in May 2013. Some of the outer laminate foil pouches may allow in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. The likelihood of the packaging defects decreasing the effectiveness of LIPTRUZET on a patient’s lipid profile or negatively impacting the safety of the product is remote. The decision to recall LIPTRUZET was not based on any reported adverse experiences or product quality complaints.
The recall will deplete all available supply in the US, and stock-outs are expected. The two active ingredients remain available: ZETIA (ezetimibe), from Merck, and atorvastatin is available as a generic from multiple manufacturers. The recall does not affect any other products manufactured by Merck.
Merck is working with FDA on this recall. Merck is informing wholesalers in the US. The medicine is not being recalled from patients or pharmacies. Patients may continue taking LIPTRUZET in their possession as prescribed by their health care provider. Patients who have questions are encouraged to talk to their health care provider, and to not stop therapy without first speaking with their physician. Merck is committed to resupplying LIPTRUZET as soon as possible.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance