Image Español You may not realize it, but most flour is a raw food. And it hasn’t been treated to kill any bacteria (germs) it may contain. Cooking and baking is what kills any bacteria in flour, as well as in raw eggs that are often used with it. To stay safe, don’t eat or…
Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication – FDA Warns of Rare but Serious Drug Reaction
[Posted 11/28/2023] AUDIENCE: Patient, Health Professional, Neurology, Dermatology, Allergy and Immunology, Pharmacy ISSUE: The FDA is warning that the antiseizure medicines, Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction…
BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy
[Posted 11/28/2023] TOPIC: BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy AUDIENCE: Patient, Health Professional, Risk Manager, Oncology, Pharmacy ISSUE: The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous…
Baxter Issues Urgent Medical Device Correction for Novum IQ Syringe Infusion Pump Due to Potential Impact of Downstream Occlusions on Infusion Volume
Summary Company Announcement Date: November 29, 2023 FDA Publish Date: November 30, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for an incomplete infusion following one or more downstream occlusion alarms. Company Name: Baxter International, Inc. Brand Name: Brand Name(s) Product Description: Product Description Novum IQ syringe infusion pump. Company Announcement…
Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes
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 Product Names: BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module Model Numbers: 8110, 8015, 8120 Distribution Dates: June 19, 2004 to September 22, 2023…
Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line
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. Please be aware, this recall is a voluntary correction, not a product removal. Eitan Medical Ltd will be updating affected devices to address this issue. Recalled Product: Product Name:…
Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Date Issued: November 30, 2023 The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic…
Meta Herbal Issues Voluntary Nationwide Recall of Magnum XXL 9800 Capsules Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: November 29, 2023 FDA Publish Date: November 29, 2023 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil Company Name: Meta Herbal Brand Name: Brand Name(s) Product Description: Product Description Magnum Male Sexual Enhancement XXL 9800 capsule Company Announcement FOR IMMEDIATE RELEASE – November 28, 2023 – E….
Braces Have Changed, From Metal to Tooth-Colored to Clear
[embedded content] Español Your dentist tells you that you need braces, bringing back not-so-fond memories of kids being called “Metal Mouth.” Take heart. Braces have evolved over the years and new alternatives in both look and materials are available. FDA is responsible for reviewing these devices for safety and effectiveness and, as appropriate, granting marketing…
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
Date Issued: November 28, 2023 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs…