For the bacteria listed below, susceptibility test interpretive criteria are not recognized at this time: Other Non-Enterobacterales
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 …
Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 25-713252 Product: Biologics Recipient: Recipient Name George Kaltner Recipient Title Chief Executive Officer and President Cellebration LLC (b)(6) San Juan 00909 Puerto Rico george@ …
Docket Number: FDA-1997-D-0029 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health This guidance outlines general validation principles that the Food and Drug Administration (FDA) …
Learn about hidden ingredients in sleep, skin and bodybuilding products so you can make informed decisions about buying or using them. Here's What You Need to Know Many products that claim to help with sleep, skin concerns or issues and bodybuilding …
Delivery Method: Via Electronic Mail Return Confirmation Requested Reference #: 320-25-109 Product: Drugs Recipient: Recipient Name Mr. Zeng Dong Recipient Title General Manager Chengdu Brilliant Biopharmaceutical Co., Ltd. #33, Tengfei 12th Rd, Southwest …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Seann Gloss PureRawz 1404 Lakeshire Dr. Knoxville, TN 37922 United States support@purerawz.co Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Gennady Sirota Recipient Title President Stellalife, Inc. P.O. Box 1204 Northbrook, IL 60065 United States support@StellaLife.com Issuing Office: Center for Drug Evaluation and Research ( …
Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. John Yi Recipient Title General Manager Janssen Vaccines Corp., A Johnson & Johnson Company 23, Harmony-ro 303beon-gil Yeonsu-gu Incheon 22014 South Korea Issuing …
Recipient: cheaptrustedpharmacy.com Turks & Caicos Islands 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 …
Recipient: motionpharmacy.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 UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-02 Product: Drugs Recipient: Recipient Name Ralph A. DeFronzo, M.D. Recipient Title Department of Medicine, Diabetes Division Ralph A. DeFronzo, M.D./University of Texas …
[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use SILINTAN, a product promoted and sold for joint pain on various websites, including 123herbals.com, and possibly in some retail stores. FDA laboratory analysis …
[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Agebox iKids Growth Day Formula, a product promoted and sold to stimulate growth and promote health in children ages five and older. Agebox iKids Growth Day Formula …
[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Agebox iKids Growth Night Formula, a product promoted and sold to stimulate growth and promote health in children ages five and older. Agebox iKids Growth Night …
CLOZARIL (clozapine) NDA 019758 Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA) Veterans Health Administration (VHA) medical and pharmacy records Descriptive study In FDA’s review of the effectiveness of the clozapine …
For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential …
FDA News Release Agency initiates safety label change and notifies physicians of possible link For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and …
Docket Number: FDA-2025-D-0918 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drugs …
Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 21, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination …
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