Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Crystalization Company Name: Zydus Pharmaceuticals Inc. Brand Name: Brand Name(s) Zydus Pharmaceuticals Product Description: Product Description Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials Company Announcement Pennington, NJ,…
Benzedrex (propylhexedrine): Drug Safety Communication – FDA Warns that Abuse and Misuse of the Nasal Decongestant Causes Serious Harm
[Posted 03/25/2021] AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: The FDA is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Some of these complications, which include fast or abnormal heart rhythm, high blood pressure, and paranoia, can lead to hospitalization,…
Lo que hay que saber sobre los síntomas, diagnóstico y tratamiento de un traumatismo craneoencefálico
Image English Un accidente automovilístico, una “tacleada” de fútbol o una caída desafortunada, todas estas cosas —entre otras— pueden causar lesiones en la cabeza. Cualquier persona, a cualquier edad, puede sufrir estas lesiones, las cuales pueden dañar el cerebro. El daño puede ocasionarse de tales formas: un movimiento brusco de la cabeza y el cerebro…
Traumatic Brain Injury: What to Know About Symptoms, Diagnosis, and Treatment
Image Español A car accident. A football tackle. An unfortunate fall. These things—and more—can cause head injuries. Head injuries can happen to anyone, at any age, and they can damage the brain. Here’s how damage can happen: A sudden movement of the head and brain can cause the brain to bounce or twist in the…
Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: March 26, 2021 FDA Publish Date: March 26, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: Namoo Enterprise LLC Brand Name: Brand Name(s) PremierZen Product Description: Product Description Dietary Supplement for male sexual enhancement Company Announcement Little Ferry, NJ, Namoo Enterprise LLC is…
S&B Shopper LLC Issues Voluntary Nationwide Recall of Imperial Extreme 2000mg Due to Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: March 25, 2021 FDA Publish Date: March 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil & Tadalafil Company Name: S&B Shopper LLC Brand Name: Brand Name(s) Product Description: Product Description Dietary Supplement for Male Enhancement Company Announcement S&B Shopper LLC is voluntarily recalling all lots of…
Medtronic Recalls Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible High Levels of Endotoxins
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface Model BBP241 Lot: 13340434 Perfusion Tubing Packs built with the affected Affinity Pixie™ CVR Models: BB10H89R4, HY10J00R6, HY11B40R1…
Learn More About COVID-19 Vaccines From the FDA
[embedded content] The U.S. Food and Drug Administration has authorized three COVID-19 vaccines for emergency use. The vaccines are: Emergency use authorization (EUA) allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDA’s Center for Biologics Evaluation and Research (CBER). Who approves COVID-19 vaccines? The FDA…
ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product ACIST Kodama Intravascular Ultrasound Catheter Lots: 00233370, 00233371, 00233372, 00233373, 00233385 Distribution Dates: November 10, 2020 to January 14, 2021 Devices Recalled in the U.S.: 490 Date…
Radiation-Emitting Products
From medical X-ray scanners used to see inside the body to surgical lasers used for cosmetic purposes or to improve eyesight, FDA ensures the safety and effectiveness of a wide range or products that emit radiation. To learn more, read these Consumer Updates. Content current as of: 04/22/2019 Regulated Product(s) Article source: http://www.fda.gov/consumers/consumer-updates/radiation-emitting-products