FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on November 29, 2023 - 00:55 GMT

BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication - FDA ...

[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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 28, 2023 - 19:26 GMT

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 28, 2023 - 19:13 GMT

Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety ...

[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 ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 27, 2023 - 17:49 GMT

Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections

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: VariSoft Infusion Sets Product Codes: FPA Model Numbers: 1002827, 1002828, 1002830 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 27, 2023 - 16:35 GMT

Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/...

Summary Company Announcement Date: November 24, 2023 FDA Publish Date: November 27, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to crystallization formation Company Name: Novartis Pharmaceuticals Corporation Brand Name: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 24, 2023 - 19:57 GMT

Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 21, 2023 - 19:15 GMT

Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication

Date Issued: November 21, 2023 The U.S. Food and Drug Administration (FDA) is providing additional information about a product recall related to the use of SoClean2 and SoClean3 equipment used to clean, sanitize, or disinfect CPAP devices and accessories. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 21, 2023 - 18:24 GMT

Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 21, 2023 - 14:01 GMT

Noah’s Wholesale, LLC Issues Voluntary Nationwide Recall of the Rock Due to Presence of Undeclared Sildenafil

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 20, 2023 - 16:21 GMT

Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps

November 20, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the FDA further evaluates this …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 17, 2023 - 15:56 GMT

KinderFarms, LLC Voluntarily Recalling all KinderMed Pain & Fever Products Due to Acetaminophen Instability

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 17, 2023 - 14:38 GMT

B. Braun Medical, Inc. recalls Infusomat® Space® Large Volume Pump, Wireless and Infusomat® Space® Large Volume Pump, and Non-...

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 correction, not a product removal. Recalled Product Device Use The Infusomat® …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 17, 2023 - 05:00 GMT

B. Braun Medical, Inc. Recalls Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless ...

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 correction, not a product removal. Recalled Product Device Use The Infusomat …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 16, 2023 - 20:29 GMT

Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted ...

Please be aware, this recall is a correction, not a product removal. 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 (Include the following …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 15, 2023 - 20:13 GMT

Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages

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 Device Use The Fresenius Medical Care Sanxin Single Use Sterile Syringes are used during …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 15, 2023 - 20:13 GMT

Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing

Please be aware, this recall is a correction, not a product removal. 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: Novum IQ …

Distribution channels:

Published on November 15, 2023 - 18:07 GMT

Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels:

Published on November 14, 2023 - 20:16 GMT

Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps

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 correction, not a product removal. Recalled Product Device Use Cardinal Health …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 13, 2023 - 20:10 GMT

Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products

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 (Include the following information) Product Names: McGRATH™ MAC Video Laryngoscopes Product Codes: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 12, 2023 - 10:46 GMT

InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels: Healthcare & Pharmaceuticals Industry