Medical Devices Archives - Page 17 of 27

Medtronic to Halt Production and Distribution of Certain Drug Pumps

May 24, 2015 By US Recall News Leave a Comment

In compliance with a consent decree filed by the U.S. Food and Drug Administration (FDA), Medtronic has agreed to stop production and distribution of Synchromed II drug pumps, except in special cases. The problem with the defective pumps is that they can deliver too much or too little medication, or patients may experience delayed therapy. The … [Read more...]

FDA Requiring New Information on Prescription Labels regarding Pregnancy, Breastfeeding, and Fertility

May 13, 2015 By US Recall News Leave a Comment

The U.S. Food and Drug Administration (FDA) has made a much-needed change in labelling requirements for prescription drugs. It is called the Pregnancy and Lactation Labelling Rule (PLLR), and it changes both the format and the content required on prescription labels regarding the safety and risks of taking a drug during pregnancy and while breast … [Read more...]

Endo Vaginal Mesh Settlement

May 11, 2015 By US Recall News Leave a Comment

American Medical Systems (AMS), a subsidiary of Endo International PLC, has agreed to settle about 360 vaginal mesh lawsuits. The settlement value has not been disclosed, but AMS has said that it would use $830 million for settlement funds. Transvaginal mesh is used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in … [Read more...]

Lisinopril

April 28, 2015 By US Recall News 42 Comments

Lisinopril, sold under the brand names Prinivil and Zestril, is an ACE inhibitor used to treat high blood pressure, treat heart failure, and improve survival after heart attack. According to the IMS Institute there were 102 million prescriptions for lisinopril in 2013, making it the third most prescribed drug in the U.S. Lisinopril has been linked … [Read more...]

Jobbers Wholesale Recalls Rhino 5 Plus, Maxtremezen and Extenzone for Undeclared Drug Ingredients

November 26, 2013 By The FDA Leave a Comment

Jobbers Wholesale has recalled Lot No. KWAKPMC030505175957019 of Rhino 5 Plus, Lot No. JBP-L-1270-70 of Maxtremezen and Lot No. KWAKPMC03050517 of Extenzone after FDA analysis found these products to contain undeclared desmethylcarbondenafil and dapoxetine. Desmethylcarbondenafil is a phosphodiesterase PDE-5 inhibitor which is a class of drugs … [Read more...]