FDA Press Releases

• Published on August 17, 2021 - 00:25 GMT

  

  Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N- Nitroso ...

  Summary Company Announcement Date: August 16, 2021 FDA Publish Date: August 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above acceptable daily intake level Company Name: Pfizer Brand Name: …

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• Published on August 12, 2021 - 18:53 GMT

  

  Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and ...

  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. The recall described in this notice is the same one that was announced in the Stop New Implants of the Medtronic …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 12, 2021 - 15:51 GMT

  

  Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May ...

  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  Dose IQ Safety Software (used with Spectrum IQ Infusion System) Product Code: 35723V091 Software …

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• Published on August 11, 2021 - 22:33 GMT

  

  Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine.

  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 August 10, 2021 - 22:35 GMT

  

  SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to 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 August 10, 2021 - 19:54 GMT

  

  Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode

  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: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR …

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• Published on August 10, 2021 - 13:01 GMT

  

  Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication

  Date Issued: October 8, 2021 The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 9, 2021 - 10:36 GMT

  

  Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral ...

  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 July 29, 2021 - 19:47 GMT

  

  Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions

  Philips Respironics has voluntarily recalled certain ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 22, 2021 - 19:30 GMT

  

  Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure ...

  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. The recall described in this notice is the same one that was announced in the FDA Safety Communication on June 30, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 22, 2021 - 18:20 GMT

  

  Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam

  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 Mechanical ventilation devices: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent 200, BiPAP …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 21, 2021 - 17:37 GMT

  

  Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Error

  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 GENOSYL DS; Nitric Oxide Delivery System Model Number: 601588-01 Serial Numbers: All Devices …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 20, 2021 - 14:38 GMT

  

  Statins: Drug Safety Communication - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During ...

  [Posted 07/20/2021]  AUDIENCE: Patient, Health Professional, OBGYN, Cardiology, Endocrinology, Pharmacy    ISSUE: The FDA is requesting revisions to the information about use in pregnancy in the prescribing information of the entire class of statin …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 19, 2021 - 19:00 GMT

  

  Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

  Summary Company Announcement Date: July 16, 2021 FDA Publish Date: July 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above ADI level Company Name: Pfizer Brand Name: Product Description: …

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• Published on July 15, 2021 - 18:38 GMT

  

  Potential Concerns with NuVasive MAGEC System Implants - FDA Safety Communication

  Date Issued: July 15, 2021 The U.S. Food and Drug Administration (FDA) is informing patients, their caregivers, and health care providers of potential mechanical failures and concerns about tissue incompatibility (biocompatibility) associated with …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 15, 2021 - 00:27 GMT

  

  Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products Due to the ...

  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 …

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• Published on July 12, 2021 - 14:54 GMT

  

  Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

  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 July 12, 2021 - 14:45 GMT

  

  Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency

  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 July 10, 2021 - 10:11 GMT

  

  UPDATE: Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers

  October 7, 2021 The U.S. Food and Drug Administration (FDA) is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers and staples for internal …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 9, 2021 - 18:47 GMT

  

  ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the ...

  Summary Company Announcement Date: September 03, 2021 FDA Publish Date: September 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of visible particulate matter Company Name: ICU Medical, Inc. Brand Name: Product …

  Distribution channels: Healthcare & Pharmaceuticals Industry