FDA Archives | Page 105 of 144

August 5, 2022

Published by Med Search on August 5, 2022

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Human Drug Compounding Outsourcing Facility Fees

Human Compounding Fee Payment Instructions When are fees incurred?Beginning in fiscal year (FY) 2015, outsourcing facilities that register with the FDA may incur one or more […]

August 5, 2022

Published by Med Search on August 5, 2022

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American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: November 08, 2019 FDA Publish Date: November 08, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company […]

August 5, 2022

Published by Med Search on August 5, 2022

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FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

For Immediate Release: August 05, 2022 Today, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable […]

August 5, 2022

Published by Med Search on August 5, 2022

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FluxxLab LLC – 637158 – 08/04/2022

Product: Drugs Recipient: Recipient Name Arend John Kuijvenhoven FluxxLab LLC 1681 Niagara Rd.Montrose, CO 81401United States [email protected] WARNING LETTER RE: 637158 Date: August 4, 2022 TO: Arend […]

August 5, 2022

Published by Med Search on August 5, 2022

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August 5, 2022 Posting | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Black salve Products containing sanguinarine, Sanguinaria canadensis, bloodroot, and zinc chloride Soft tissue necrosis FDA Consumer Update: Drugs – Do Not Use: Black Salve is Dangerous […]

August 5, 2022

Published by Med Search on August 5, 2022

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Why is FDA posting a list outside the usual quarterly timeframe?

The potential signals that FDA posts to this web page are derived in part from a computer tracking system in CDER. In April 2020, CDER made […]

August 5, 2022

Published by Med Search on August 5, 2022

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VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

Summary Company Announcement Date: August 04, 2022 FDA Publish Date: August 04, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination with Gluconacetobacter […]

August 4, 2022

Published by Med Search on August 4, 2022

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Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Summary Company Announcement Date: August 03, 2022 FDA Publish Date: August 04, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: […]

August 4, 2022

Published by Med Search on August 4, 2022

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MedWatch Tips and Tricks Transcript

Video Script: When you, the health care professional, voluntarily report observed or suspected adverse events to FDA’s MedWatch program, you provide a vital source of information […]