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July 20, 2020

LIQ-E S.A. de C.V. Issues Voluntary Recall of the Optimus Instant Hand Sanitizer Due to the Potential Presence of Undeclared Methanol

Summary Company Announcement Date: July 20, 2020 FDA Publish Date: July 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company […]
July 20, 2020

FDA Protects Patients and Consumers from Fraud During COVID-19

Image By: Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs, and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs Throughout the pandemic, the […]
July 20, 2020

Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process

In this CDER Conversation, Sally Choe, director of the Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs and Mike Kopcha director of CDER’s […]
July 20, 2020

FDA’s Continued Commitment to the Safety and Security of Our Laboratories

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and RADM Denise Hinton, Chief Scientist The FDA is known for its mission to protect […]
July 20, 2020

New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program

CDER Conversation with Robyn Bent, Director of Patient-Focused Drug Development and Program Officer for the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant […]
July 18, 2020

InHe Manufacturing, LLC and MHR Brands Issues Voluntary Nationwide Recall of Several Products Due to Potential Health Risk for Excess Lead

This recall press release was issued by the firm on 06-23-2020 and is subsequently being posted by FDA at this time only to benefit the public […]
July 17, 2020

Pharmaboosters.com – 607929 – 07/09/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United […]
July 17, 2020

Hydroxychloroquine-online.com – 607727 – 07/09/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United […]
July 16, 2020

Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination

Summary Company Announcement Date: December 18, 2019 FDA Publish Date: December 18, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Bacillus subtilis Company Name: […]
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