U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on December 23, 2025 - 16:47 GMT

Pinnacle Professional Research dba Pinnacle Peptides - 719337 - 12/12/2025

Delivery Method: Via Email Product: Drugs Recipient: Pinnacle Professional Research dba Pinnacle Peptides 1001 N Elm Street, Suite 31 Greensboro, NC 27401 United States service@pinnaclepeptides.com Issuing Office: Center for Drug Evaluation and Research ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 16:47 GMT

Dynamic Health Group dba SARMS AMERICA - 719257 - 12/12/2025

Delivery Method: Via Email Product: Drugs WARNING LETTER December 12, 2025 RE: 719257 Dynamic Health Group dba SARMS AMERICA: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 16:47 GMT

TITAN SARMS LLC - 719645 - 12/12/2025

Delivery Method: Via Email Product: Drugs WARNING LETTER December 12, 2025 TITAN SARMS LLC Jedediah Bigelow, Legal Counsel 30 N. Gould St., Suite R Sheridan, WY 82801 RE: 719645 TITAN SARMS LLC: This letter is to advise you that the U.S. Food and Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 16:47 GMT

Maria A. Carballosa, M.D. - 720805 - 12/12/2025

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-12-02 Product: Drugs Recipient: Maria A. Carballosa, M.D. 4395 Palm Avenue Hialeah, FL 33012-4014 United States Issuing Office: Center for Drug Evaluation and Research (CDER) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 16:47 GMT

Revive Rx LLC dba Revive Rx Pharmacy - 709509 - 09/22/2025

Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Aaron M. Schneider Recipient Title Chief Pharmacy Officer & Owner Revive Rx LLC dba Revive Rx Pharmacy 3831 Golf Drive, Suite A Houston, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 16:47 GMT

Medinatura New Mexico, Inc. - 716025 - 12/10/2025

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-27 Product: Drugs Recipient: Recipient Name Mr. Clifford Clive Medinatura New Mexico, Inc. 10421 Research Road SE Albuquerque, NM 87123 United States Issuing Office: Center for Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 16:47 GMT

Guangdong Renhe Guozhuang Biotechnology Co., Ltd. - 719045 - 12/16/2025

Delivery Method: Via Email Reference #: 320-26-29 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Zhou Yigang Recipient Title Production Manager Guangdong Renhe Guozhuang Biotechnology Co., Ltd. No. 5, Tongfu Road, Xicheng Industrial …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 16:47 GMT

Darmerica, LLC - 716152 - 12/08/2025

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-24 Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-24 December 8, 2025 Dear Mr. Hamza: The United States Food and Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 01:42 GMT

RIASTAP

STN# 125317 Proper Name: Fibrinogen Concentrate (Human) Tradename: RIASTAP Manufacturer: CSL Behring GmbH Indication: Treatment of of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 01:42 GMT

Plasminogen, Human-tvmh

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 01:42 GMT

Pooled Plasma (Human), Solvent/Detergent Treated

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 01:42 GMT

Prothrombin Complex Concentrate, Human-LANS

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2025 - 01:42 GMT

Adverse Events and Product Deviation Guidances

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 23:36 GMT

Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo),...

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: Food & Beverage Industry

Published on December 22, 2025 - 23:35 GMT

FDA approves drug to improve functional capacity and symptoms in adults with rare inherited heart condition

Action The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Disease or Condition Symptomatic oHCM is an …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 23:35 GMT

FDA approves first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older

Action The U.S. Food and Drug Administration (FDA) approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older with iron deficiency. Accrufer was initially approved in 2019 for adults with iron deficiency. Disease or Condition …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 22:41 GMT

Troemner Roemner Farm Issues Allergy Alert on Undeclared Milk, Wheat, and Soy in Pfeffernusse Cookies

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: Food & Beverage Industry

Published on December 22, 2025 - 16:25 GMT

Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

AUDIENCE: Patient, Health Care Professional, Pharmacy, Hematology ISSUE: Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 16:25 GMT

Coagulation Factor Xa (Recombinant), Inactivated-ZHZO

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 16:25 GMT

Coagulation Factors

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry