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November 3, 2020

Cosmax USA, Inc. – 606909 – 10/15/2020

Delivery Method: UPS Product: Drugs Recipient: Recipient Name President/Co-Chief Executive Officer Cosmax USA, Inc. Mr. Byung Joo Lee 65 Challenger RoadRidgefield Park, NJ 07660United States Issuing […]
November 3, 2020

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily […]
November 2, 2020

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily […]
November 2, 2020

Spartan Enterprises Inc. dba Watershed Wellness Center – 610876 – 10/30/2020

Product: Drugs Recipient: Recipient Name Robert McCauley Spartan Enterprises Inc. dba Watershed Wellness Center 16280 National ParkwayLansing, MI 48906United States [email protected] [email protected] Date: October 30, 2020 […]
October 30, 2020

FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities

For Immediate Release: October 30, 2020 Recently, leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration […]
October 30, 2020

December 16, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement – 12/16/2020 – 12/16/2020

On This Page Date: December 16, 2020 Time: 9:00 AM – 1:30 PM ET Center Date Time Location CDER December 16, 2020 9 a.m. to 1:30 p.m. […]
October 30, 2020

Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs

Introduction On August 6, 2020, the President issued an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. […]
October 29, 2020

FDA Adverse Event Reporting System (FAERS) Public Dashboard

The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user friendly fashion. The intention […]
October 29, 2020

2018 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee

2018 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee | FDA In this section: Peripheral and Central Nervous System Drugs Advisory Committee Home Advisory […]
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