FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 12, 2022 - 22:56 GMT

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin ...

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 April 11, 2022 - 17:32 GMT

Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers

April 11, 2022 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO). LVO is an obstruction …

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Published on April 5, 2022 - 14:11 GMT

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Date Issued: April 5, 2022 The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as …

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Published on April 4, 2022 - 17:22 GMT

UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers

April 4, 2022 As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for …

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Published on March 30, 2022 - 21:59 GMT

Iodine-Containing Contrast Media: Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who ...

[Posted 03/30/2022] AUDIENCE: Pediatrics, Radiology, Health Professional, Patient, Caregiver, Pharmacy ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring …

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Published on March 30, 2022 - 21:23 GMT

Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection ...

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 March 29, 2022 - 20:33 GMT

Teva Issues Voluntary Nationwide Recall of One Lot of IDArubicin Hydrochloride Injection USP 5 mg/5 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 March 25, 2022 - 00:01 GMT

Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide ...

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 March 23, 2022 - 20:16 GMT

Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only

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: Celltrion DiaTrust COVID-19 Ag Rapid Test (labeled for Research Use Only) Product …

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Published on March 23, 2022 - 00:26 GMT

Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide ...

Summary Company Announcement Date: March 22, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a nitrosamine, N-nitroso-quinapril Company Name: Pfizer Brand Name: Brand Name(s) …

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Published on March 22, 2022 - 20:40 GMT

Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results 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: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 22, 2022 - 18:38 GMT

Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential ...

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 March 22, 2022 - 16:42 GMT

Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a ...

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 March 21, 2022 - 17:31 GMT

Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel

March 21, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ …

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Published on March 21, 2022 - 14:25 GMT

Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working ...

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 V60 and V60 Plus Ventilator Product Codes and Serial Numbers: See …

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Published on March 18, 2022 - 14:37 GMT

Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication

Date Issued: March 18, 2022 The U.S. Food and Drug Administration (FDA) is alerting people that there is a potential for harm if FDA authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. The FDA is also reminding …

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Published on March 17, 2022 - 16:50 GMT

Celltrion USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf ...

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: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See …

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Published on March 17, 2022 - 01:10 GMT

SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False ...

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: SD Biosensor STANDARD Q COVID-19 Ag Home Test Product Codes and Lot Numbers: See …

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Published on March 15, 2022 - 19:59 GMT

Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

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: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See …

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Published on March 14, 2022 - 17:19 GMT

LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not ...

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: COVID-19 Antigen Test (Saliva) COVID-19 Antigen Test (Nasal) COVID-19 IgG/IgM …

Distribution channels: Healthcare & Pharmaceuticals Industry