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June 4, 2020

Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling

Summary Company Announcement Date: April 21, 2019 FDA Publish Date: July 15, 2019 Product Type: DrugsPrescription Drugs Reason for Announcement: Recall Reason Description Due to Product […]
June 4, 2020

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Summary Company Announcement Date: August 27, 2018 FDA Publish Date: March 19, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Labeling Mix-up […]
June 3, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 3, 2020

For Immediate Release: June 03, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 3, 2020

FDA alerts health care professionals to the temporary absence of warning statement on the vial caps of two neuromuscular blocking agents

The U.S. Food and Drug Administration is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps […]
June 3, 2020

CDER’s Work to Protect Public Health During the COVID-19 Public Health Emergency

The U.S. Food and Drug Administration is working in many ways to protect our nation’s public health during the COVID-19 public health emergency. Our Center for […]
June 3, 2020

Pharmacy Compounding Advisory Committee Charter

Authority The Pharmacy Compounding Advisory Committee is required by section 503A and section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a(c)(1) and […]
June 3, 2020

Medical Imaging Drugs Advisory Committee Charter

Authority The Medical Imaging Drugs Advisory Committee was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, […]
June 3, 2020

Arthritis Advisory Committee Charter

Committee’s Official Designation (Title) Arthritis Advisory Committee Authority The Arthritis Advisory Committee was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, […]
June 2, 2020

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

Summary Company Announcement Date: May 18, 2018 FDA Publish Date: March 30, 2020 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Lack of Adequate […]
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