FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on September 14, 2020 - 18:02 GMT

Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due 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 BD Alaris™ PC Unit Model 8015, PC Unit Front Case with Keypad Replacement Kits Affected Models: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2020 - 16:32 GMT

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure

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 12, 2020 - 15:55 GMT

AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

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 11, 2020 - 15:46 GMT

Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

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 11, 2020 - 13:46 GMT

Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use

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 Trevo XP ProVue Retriever Catalog Numbers and Lot Numbers: Full List of Affected Devices …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2020 - 20:33 GMT

Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) 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 September 9, 2020 - 15:34 GMT

FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy ...

Date Issued: September 9, 2020 The FDA monitors reports of adverse events and other problems with medical devices and alerts the public when needed to ensure proper use of devices and protect the health and safety of patients and users. The FDA is issuing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 4, 2020 - 15:46 GMT

Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products

COMPANY ANNOUNCEMENT This recall has been completed and FDA has terminated this recall. 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2020 - 20:20 GMT

Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2020 - 18:28 GMT

Open Book Extracts Issues Voluntary Nationwide Recall of All Lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that ...

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 August 28, 2020 - 21:00 GMT

Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE - Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care providers that gowns sold as medical gowns, including surgical gowns, sold by Laws of Motion PPE (LawsofMotionPPE.com) have …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 28, 2020 - 18:40 GMT

Harmonic Nature Issues Voluntary Nationwide Recall of Hand Sanitizer Due to the Presence of 1-Propanol

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 August 26, 2020 - 20:16 GMT

Nanomateriales, Sa De CV Issues Voluntary Nationwide Recall of All Lots of Zanilast+gel Due to the Presence of 1-Propanol

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 26, 2020 - 14:18 GMT

Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert - Boxed Warning about Risk of Leg and Foot Amputations ...

[Posted 08/26/2020] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: Based on FDA's review of new data from three clinical trials, the boxed warning about amputation risk from the diabetes medicine canagliflozin (Invokana, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 25, 2020 - 22:13 GMT

Asiaticon SA de CV Issues Voluntary Nationwide Recall of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz ...

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 24, 2020 - 17:20 GMT

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery 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 Medfusion Syringe Pumps Model 3500, firmware version 6.0.0 Models 3500-0600-00, -01, -249, -51, -82 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 21, 2020 - 14:51 GMT

Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health ...

The U.S. Food and Drug Administration (FDA) is alerting health care providers (HCP) and health care facilities that the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2020 - 16:19 GMT

Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg ...

Summary Company Announcement Date: August 19, 2020 FDA Publish Date: August 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Bayshore …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2020 - 15:05 GMT

Grupo Asimex De Mexico Sa De CV Issues Voluntary Nationwide Recall of All Lots of Florence Morris Antiseptic Hand Sanitizer Due to ...

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 August 19, 2020 - 02:11 GMT

Grupo Yacana México S.A.S De C.V. Issues Voluntary Nationwide Recall of All Lots of Yacana Hand Sanitizer Due to 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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