FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 5, 2021 - 19:54 GMT

Hospira Issues A Voluntary Nationwide Recall for One Lot of 0.5% Bupivacaine Hydrochloride Injection, USP and One Lot of 1% ...

Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to mislabeling Company Name: Hospira, Inc. Brand Name: Brand Name(s) Product Description: Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 31, 2021 - 21:31 GMT

Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety ...

Date Issued: March 31, 2021 The U.S. Food and Drug Administration (FDA) is informing patients, caregivers, and health care providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 31, 2021 - 21:31 GMT

Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart ...

[Posted 03/31/2021] AUDIENCE: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry ISSUE: An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 31, 2021 - 16:48 GMT

Ummzy LLC Issues Voluntary Nationwide Recall of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night 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 31, 2021 - 16:48 GMT

Nuri Trading LLC Issues Voluntary Nationwide Recall of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE ...

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 31, 2021 - 04:00 GMT

Apotex Corp. Issues Voluntary Nationwide Recall of Guanfacine Extended-Release Tablets 2mg Due to Trace Amounts of Quetiapine ...

Summary Company Announcement Date: March 31, 2021 FDA Publish Date: March 31, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Trace amounts of Quetiapine Fumarate Company Name: Apotex Corp. Brand Name: Brand Name(s) Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 30, 2021 - 17:44 GMT

Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication

Date Issued: March 30, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Tennessee Women’s Care P.C., located in Nashville, Tennessee, on or after November 1, 2019, about possible problems with the quality of their …

Distribution channels:

Published on March 30, 2021 - 17:44 GMT

Bit & Bet LLC Issues Voluntary Nationwide Recall of Thumbs Up 7 Blue 69K Due to Presence of Undeclared Sildenafil and Tadalafil

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 30, 2021 - 01:14 GMT

Antoto-K Issues Voluntary Nationwide Recall of Thumbs Up 7 Red 70K Due to the Presence of Undeclared Sildenafil and Tadalafil

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 27, 2021 - 05:31 GMT

Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil 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 March 26, 2021 - 01:01 GMT

S&B Shopper LLC Issues Voluntary Nationwide Recall of Imperial Extreme 2000mg Due to Presence of Undeclared Sildenafil 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 March 25, 2021 - 15:15 GMT

BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States

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 25, 2021 - 15:15 GMT

Durisan Hand Sanitizer Recall 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 March 25, 2021 - 15:15 GMT

Benzedrex (propylhexedrine): Drug Safety Communication - FDA Warns that Abuse and Misuse of the Nasal Decongestant Causes Serious ...

[Posted 03/25/2021] AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: The FDA is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 25, 2021 - 15:15 GMT

Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization

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 24, 2021 - 22:10 GMT

Medtronic Recalls Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible High Levels 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 Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface Model BBP241 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 24, 2021 - 22:10 GMT

Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label 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 March 18, 2021 - 21:21 GMT

ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries 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 ACIST Kodama Intravascular Ultrasound Catheter Lots: 00233370, 00233371, 00233372, 00233373, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 17, 2021 - 17:10 GMT

PNHC, LLC d/b/a Heal the World Issues Voluntary Nationwide Recall of Heal the World Hand Sanitizer Packaged in 9.6 Ounce Bottles ...

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 15, 2021 - 22:12 GMT

Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication

Date Issued: March 15, 2021 The U.S. Food and Drug Administration (FDA) is advising patients, caregivers, and health care providers about the higher than expected risk of the polyethylene (plastic) component of the device breaking (fracture), as early as …

Distribution channels: Healthcare & Pharmaceuticals Industry