[10-23-2025] The Food and Drug Administration is advising consumers not to purchase or use SPARTAN, a product promoted and sold for male sexual enhancement on various websites, including www.vroxusa.com, and possibly in some retail stores. FDA laboratory …
76 218492 Prucalopride Tablets Novitium Pharma LLC Motegrity Tablets 12/26/2024 For the treatment of chronic idiopathic constipation in adults 75 215971 Deutetrabenazine Tablets Aurobindo Pharma Limited Austedo Tablets 12/26/2024 For the treatment in …
FDA’s role in drug recalls A recall may be recommended or requested by FDA or initiated voluntarily at any time by a company. FDA’s role in a recall is to oversee a company’s recall strategy and ensure adequate steps were taken to implement the recall. FDA …
For Immediate Release: October 23, 2025 The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable. …
FDA has completed its review of the rationale document titled, “Aminoglycoside Breakpoints for Enterobacterales and Pseudomonas aeruginosa” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the public docket FDA-2017-N-5925-0037 in …
S = Susceptible; I = Intermediate; R = Resistant a. Susceptibility interpretive criteria are based on a dose of 6 grams fosfomycin every 8 hours by intravenous infusion over 1 hour in patients with an estimated creatinine clearance of 50 mL/min. b. For …
Docket Number: FDA-2022-D-1385 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health FDA is posting this document to provide advance notice to …
Best Practices for Communication Between IND Sponsors and FDA During Drug Development Final Guidance Updated guidance on best practices for communication between IND sponsors and FDA during drug development. Meeting Management Goals 12/29/2017 BsUFA II: …
FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not to be administered intrathecally (into the spine) or as an …
Online Advisory Letter Reference #715639 September 8, 2025 MOLOOCO dba Ourlyard payments@mooloco.com RE: DoubleNano Advanced Lung Detox Relief Patch To whom it may concern: This letter is to advise you that the U.S. Food and Drug Administration (FDA) …
Recipient: www.usmedschoice.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States …
Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs WARNING LETTER September 9, 2025 All American Wellness: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content …
Delivery Method: VIA Electronic Mail Reference #: 320-26-04 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Veblen Liang Recipient Title General Manager Foshan Yiying Hygiene Products Co., Ltd. Industrial Building No. 3, Ruichang …
Delivery Method: VIA UPS Reference #: 320-25-117 Product: Drugs Recipient: Recipient Name Mr. Guo Guorong Recipient Title Chairman & General Manager Guangxi Yulin Pharmaceutical Group Co. Ltd. No. 1 Chengzhan Rd. Yulin Shi Guangxi Zhuangzuzizhiqu, …
Delivery Method: Via Email Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Anthony Moloney Recipient Title Group CEO Melcare Biomedical Pty Ltd 451 West Mount Cotton Rd Mount Cotton QLD 4165 Australia anthonym@melcare.com Issuing Office: …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-112 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Ms. Teresa L. Bandrowsky BRS Analytical Services, LLC 11697 Lakeside Crossing Court St. Louis, MO 63146-8606 United States …
Delivery Method: VIA UPS Reference #: 320-26-03 Product: Drugs Recipient: Recipient Name Mr. Walter C. Johnsen Acme United Corporation 1 Waterview Drive Suite 200 Shelton, CT 06484 United States Issuing Office: Center for Drug Evaluation and Research (CDER …
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 …
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 …
[10-17-2025] The Food and Drug Administration is advising consumers not to purchase or use Black Thai Honey, a product promoted and sold for male sexual enhancement on various websites, including www.honeypacks.com, and possibly in some retail stores. FDA …
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