USFDA-United States of America Archives - Page 2 of 3

Medfusion 3500 and 4000 Syringe Pumps: Class I Medical Device Recall by US-FDA

Aug 26, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, Medfusion 3500 and 4000 Syringe Pumps, USFDA Medical Device Recall

On 24-Aug-2020, US-FDA has released a recall alert for class I medical Device- Medfusion 3500 and 4000 Syringe Pumps due to risk of medication delivery error. Device Use: This is used in the delivery of following products into the patient’s body in a controlled manner. Blood Blood products Prescribed medications Other fluids Syringe pumps which…

Moxifloxacin-Drug Safety Alert from US-FDA

Aug 14, 2020Public Safety & VigilanceGlobal Safety Alerts, USFDA-United States of AmericaDrug safety alert, Moxifloxacin, TASS (Toxic Anterior Segment Syndrome)

Food & Drug Administration of United States has released a drug safety alert for Moxifloxacin to bring awareness to health care professionals with this safety information. Moxifloxacin is quinoline antibiotic which inhibits the growth of bacteria. It is used in the treatment of various bacterial infections. Moxifloxacin is available in two brand names in USA-Moxeza…

Class I Medical Device Recall: BodyGuard Infusion Pump System

Aug 8, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, US-FDA, USFDA-United States of AmericaBodyGuard Infusion Pump System, Class I medical device recall, Most serious type of medical device recall, USFDA Medical Device Recall

On 05-Aug-2020, US-FDA has released a recall alert for class I medical Device- BodyGuard Infusion Pump System due to the risk of over-fusion and under-infusion. Class I Medical Device Recall: As per the classification system by US-FDA, this device falls under the category of Class I medical device. This is the most serious type of…

USFDA Drug Safety Communication: Naloxone use for opioid use disorder

Jul 28, 2020Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reportingNaloxone, Opioid overdose, Opioid use disorder, USFDA Drug Safety Communication

On 23-Jul-2020, United States Food and Drug Administration (USFDA) has released a recommendation for the use of Naloxone in the treatment of opioid use disorder and for patients who are at increased risk of opioid overdose. Opioids are a class of drugs which are used to reduce moderate to severe pain in patients who are…

Recall of Class I Medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”)

Jul 18, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, GlideScope Core One TouchSmart Cable, USFDA Medical Device Recall

On 17-Jul-2020, US-FDA released a recall alert for class I medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”) due to partial or complete loss of image during use. Device Use: The GlideScope Core Video Laryngoscopy System is intended to provide a clear view of the airway and vocal cords for medical procedures. The Core…

Recall of Class I Medical Device- Arrow AutoCAT®2 and AC3 Optimus® IABP Series

Jul 4, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaArrow AutoCAT®2 and AC3 Optimus® IABP Series, Class I medical device recall, USFDA Medical Device Recall

On 02-Jul-2020, US-FDA released a recall alert for class I medical Device– Arrow AutoCAT®2 and AC3 Optimus® IABP Series due to possible breakdown of motor connector wires. Device Use: The Arrow AutoCAT®2 and AC3 Optimus® are Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices which are used for patients who are undergoing cardiac and non-cardiac…

An unfavourable benefit-risk profile for Hydroxychloroquine in the COVID-19 treatment

Jul 2, 2020Public Safety & VigilanceCOVID-19 Medication, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety Communications, USFDA-United States of America, Voluntary ADR reportingchloroquine, COVID-19 treatment, Emergency Use Authorization, Hydroxychloroquine, Revoke of EUA

Hydroxychloroquine is an antimalarial class of drug which is used in the treatment and prevention of acute attacks of malaria. It is also used to treat discoid or systemic lupus erythematosus, rheumatic disorders like rheumatoid arthritis, porphyria cutanea tarda and Q fever. Hydroxychloroquine acts by increasing pH within intracellular vacuoles and alter processes such as protein…

Recall of Class I Medical Device- Ovation iX Abdominal Stent Graft Systems

Jun 17, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaOvation iX Abdominal Stent Graft Systems, Recall of Class I medical Device, USFDA Medical Device Recall

On 16-Jun-2020, US-FDA released a recall alert for class I medical Device– Ovation iX Abdominal Stent Graft Systems due to the risks of polymer leaks during implantation Device Use: This device is used in endovascular treatment for patients with an abdominal aortic or aortoiliac aneurysms (AAA). Aortic Aneurysm is a condition which occurs when the aorta…

Metformin Hydrochloride Extended-Release (ER) Tablets: Another voluntary recall

Jun 12, 2020Public Safety & VigilanceDrug Recall, Drug Safety Updates, Global Safety Alerts, Pharmacovigilance, USFDA-United States of America, Voluntary ADR reportingMetformin ER, Metformin ER Voluntary Recall, Metformin Extended Release, NMDA, Voluntary recall

On 11-Jun-2020, a nationwide recall of one lot of Metformin Hydrochloride ER Tablets USP, 500 mg [Lot Number: G901203] issued by Lupin Pharmaceuticals, Inc. due to the detection of N-Nitrosodimethylamine (NDMA). Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. NDMA…

Class I Medical Device Recall: Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0

Jun 3, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, Most serious type of medical device recall, USFDA Medical Device Recall

On 01-Jun-2020, US-FDA has released a recall alert for class I medical Device– StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License Device Use: This device is used during a deep brain stimulation (DBS) procedure which provides images…

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