FDA Press Releases

• Published on October 26, 2022 - 03:23 GMT

  

  Mylan Institutional LLC, a Viatris Company, Issues a Voluntary Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due ...

  Summary Company Announcement Date: October 25, 2022 FDA Publish Date: October 25, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to glass particulates Company Name: Mylan Institutional LLC, a Viatris company Brand Name: …

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• Published on October 25, 2022 - 17:09 GMT

  

  Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP ...

  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 …

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• Published on October 25, 2022 - 15:24 GMT

  

  Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication

  Date Issued: October 25, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers and health care providers not to use the recalled Mighty Bliss electric heating pads distributed by Whele LLC (doing business as Perch) due to the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 24, 2022 - 18:41 GMT

  

  Whele LLC Announces National Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns

  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 …

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• Published on October 24, 2022 - 13:08 GMT

  

  Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds ...

  Summary Company Announcement Date: October 21, 2022 FDA Publish Date: October 24, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for radio frequency (RF) interference with other medical devices. Company Name …

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• Published on October 19, 2022 - 12:51 GMT

  

  Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain ...

  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: Amara View Full Face Mask DreamWisp Nasal Mask DreamWear Full Face Mask Wisp and …

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• Published on October 13, 2022 - 15:04 GMT

  

  Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-...

  Summary Company Announcement Date: October 12, 2022 FDA Publish Date: October 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Product …

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• Published on October 12, 2022 - 17:38 GMT

  

  Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA

  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 Name: COVID-19 Ag Rapid Test Device Product Codes: See Recall Database Entry Distribution …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 1, 2022 - 00:59 GMT

  

  Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due ...

  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 …

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• Published on October 1, 2022 - 00:59 GMT

  

  LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

  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 Name: LifeSPARC System  Product Model: LifeSPARC Controller, Model LS-1000 Distribution …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 28, 2022 - 23:32 GMT

  

  Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared ...

  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 …

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• Published on September 27, 2022 - 16:47 GMT

  

  Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of ...

  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 September 23, 2022 - 15:55 GMT

  

  Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern

  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 Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+ Product Models: A- …

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• Published on September 20, 2022 - 12:34 GMT

  

  Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% 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 View Product Photos …

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• Published on September 16, 2022 - 19:02 GMT

  

  Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature ...

  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 September 16, 2022 - 18:26 GMT

  

  Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature ...

  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 September 16, 2022 - 17:15 GMT

  

  Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health ...

  September 16, 2022 The U.S. Food and Drug Administration (FDA) is updating the Letter to Health Care Providers issued on April 27, 2022, to ensure health care providers in the operating room setting are aware of the voluntary recall initiated by Medtronic …

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• Published on September 15, 2022 - 13:34 GMT

  

  Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers 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. Recalled Product  Product Name: Clearlink Basic Solution Set with Duovent Product Code: 2R8403 (all lots within …

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• Published on September 12, 2022 - 11:04 GMT

  

  Remel, Inc Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible results

  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 Name: Thermo Scientific Gram Negative IVD AST Sensititre Plate  Catalog Number: GN2F, GN3F …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 12, 2022 - 04:00 GMT

  

  Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of ...

  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 Name: NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG …

  Distribution channels: Healthcare & Pharmaceuticals Industry