FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 12, 2022 - 17:06 GMT

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg, 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 January 12, 2022 - 15:40 GMT

Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and ...

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 January 11, 2022 - 18:11 GMT

2022 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2022 Safety Communications Content current as of: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2022 - 18:11 GMT

Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication

Date Issued: January 11, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2022 - 14:16 GMT

Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to ...

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 Iso-Gard Filter S filters are breathing circuit bacterial filters that are connected to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 10, 2022 - 16:07 GMT

Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval

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: WIRION Embolic Protection Device Product Codes: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2022 - 11:05 GMT

North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by ...

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: Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit, may also be called: Oral Rapid Test or …

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Published on January 7, 2022 - 10:18 GMT

Information Regarding Medically Necessary Specialty Infant Formulas: Notice to Health Care Providers

July 1, 2022 The U.S. Food and Drug Administration is providing information to health care professionals to help their patients obtain access to medically necessary specialty, amino acid-based and metabolic infant formula products. The FDA is continuing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2022 - 19:36 GMT

Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug ...

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 January 6, 2022 - 19:11 GMT

Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

[Posted 06/01/2022] AUDIENCE: Oncology, Patient, Health Professional, Pharmacy   ISSUE: Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from the UNITY-CLL clinical trial continued …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2022 - 18:59 GMT

Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge ...

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: Synergy Cranial and StealthStation S7 Cranial Software Model Numbers: See Recall …

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Published on January 4, 2022 - 19:04 GMT

Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to 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 …

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Published on January 4, 2022 - 17:49 GMT

F&S Medical Supply, DBA Pink Toyz Issues Voluntary Nationwide Recall of Pink Pussycat 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2022 - 18:13 GMT

2022 Medical Device Recalls

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Published on January 3, 2022 - 18:13 GMT

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly 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 Product Names: Puritan Bennett 980 Series Ventilator Model Numbers: See Recall Database Entries …

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Published on January 3, 2022 - 15:05 GMT

Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication

Date Issued: March 1, 2021 The U.S. Food and Drug Administration (FDA) is warning people not to use certain ACON Laboratories COVID-19 tests. People should not use the ACON Laboratories test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2022 - 13:31 GMT

Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication

Date Issued: March 1, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test. The test is not authorized, cleared, or approved by the FDA for distribution or use in the United …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2022 - 12:03 GMT

Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication

Date Issued: March 1, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use certain Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Tests. People should not use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white …

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Published on December 30, 2021 - 15:31 GMT

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot ...

Summary Company Announcement Date: December 27, 2021 FDA Publish Date: December 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Ralstonia pickettii bacteria Company Name: Taro Pharmaceuticals USA, Inc. Brand Name …

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Published on December 27, 2021 - 20:51 GMT

Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

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