USFDA alerts Archives - Public Safety & Vigilance

Hydrochlorothiazide: Drug Safety Update (Label Changes) from USFDA

Aug 30, 2020Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, US-FDA, USFDA-United States of AmericaDrug Safety Label Update, Hydrochlorothiazide, USFDA alerts

A new safety labelling change for hydrochlorothiazide (HCTZ) drug was approved by United States Food and Drug Administration (US-FDA). Hydrochlorothiazide is loop diuretic (acts on kidneys by eliminating excess fluids) used in the treatment of high blood pressure and oedema associated with the congestive heart failure. A new safety information identified through routine pharmacovigilance (PV)…

Recall of a Class I Medical Device: IMAGER II 5F Angiographic Catheters

Apr 9, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, USFDA-United States of AmericaBoston Scientific Corporation, Class I medical Device, IMAGER II 5F Angiographic Catheters, Most serious type of medical device recall, Recall of Class I medical Device, USFDA alerts, USFDA Medical Device Recall

A serious type of recall for medical device class I has announced by FDA for the Boston Scientific Corporation IMAGER II 5F Angiographic Catheters. This class I device is used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries during angiography. During the patient procedure preparation, potential for the catheter…

Recall of a Class I Medical Device: A most serious type recall

Apr 7, 2020Public Safety & VigilanceMedical Device, Medical Device Recall, Medical Device UpdatesClass I medical Device, Class I medical device recall, LeMaitre Over the Wire Embolectomy Catheter, Medical Device Recall, Most serious type of medical device recall, USFDA alerts

The announcement of recall and withdrawal of medicinal products and medical devices of class II and class III from market is considered usual. The recall scenario of a class I medical device due to serious injury to patient’s health is very rare and requires quite attention. Class I medical devices are “considered safe” which does not…

Drug Recall story of Ranitidine (An established drug since 3 decades)

Apr 3, 2020Public Safety & VigilanceDrug Recall, Drug Safety Updates, Global Safety Alerts, Pharmacovigilance, Safety Communications, USFDA-United States of AmericaDrug Recall, Drug safety alert, patientsafety, Ranitidine, USFDA alerts, Zantac

A medicine having been considered as “Safe” since 1981 is recalled from the drug market. It’s not a surprise on recall of a drug from market which has an “assumed established safety profile”. Ranitidine, popularly known to public as Zantac, is a very common OTC (over the counter) drug and prescription stomach acid blocker widely…

Public Safety & Vigilance

A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.