Availability of Ancom Anti-Hypertensive Compound Tablets has caused one adverse event so far, FDA says March 17. Tai Chien is recalling all 100-count bottles of the product because they contain several Rx ingredients, including diazepam, promethiazine, reserpine, which may pose health risks such as "sedation, depression and potentially life-threatening abnormalities of the blood," agency notes. Herbsland recalled same product in January (1"The Tan Sheet" Jan. 20, 2003, p. 8). Tablets are manufactured by Shanghai Pharmaceutical, sold at retail stories in New York City, online...

There could be 28 notified body designations in total under the Medical Device Regulation by the end of 2021. But there is cause for concern over designations under the IVD Regulation, which are lagging far behind.

A consortium of Swiss providers, patient groups and health care trade bodies is imploring the federal council to avert a looming patient care crisis in Switzerland if the EU MRA cannot be agreed.