FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

Distribution channels:

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 …

Distribution channels:

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 …

Distribution channels:

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 …

Distribution channels:

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) …

Distribution channels:

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 …

Distribution channels:

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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/ …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 14, 2022 - 15:37 GMT

FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

Date Issued: March 14, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures. Specifically, the FDA is warning …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2022 - 23:17 GMT

ACON Laboratories Issues a Recall of Non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U....

Summary Company Announcement Date: January 09, 2022 FDA Publish Date: March 11, 2022 Product Type: Medical Devices Counterfeit Reason for Announcement: Recall Reason Description Unauthorized U.S. distribution-counterfeited product Company Name: ACON …

Distribution channels:

Published on March 11, 2022 - 19:23 GMT

Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ ...

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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Spectrum IQ Infusion …

Distribution channels:

Published on March 11, 2022 - 11:03 GMT

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication

Date issued: 11/3/2022 The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2022 - 00:26 GMT

Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

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: