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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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: […]
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 […]
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