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June 4, 2020

Two Neuromuscular Blocking Agents: CDER Alert – FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps

[Posted 06/03/2020] AUDIENCE: Health Professional, Pharmacy, Risk Manager ISSUE:  FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed […]
June 4, 2020

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: January 07, 2020 FDA Publish Date: January 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company […]
June 4, 2020

Andropharm Issues Voluntary Nationwide Recall of Sten Z and M1 Alpha Due to Labeling that it Contains Derivatives of Anabolic Steroids

Summary Company Announcement Date: July 11, 2017 FDA Publish Date: February 08, 2018 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Contain derivatives of […]
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 […]
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