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January 28, 2021

Allimax Us – 609328 – 01/12/2021

Product: DrugsFood & Beverages Recipient: Recipient Name Bobbi Walton Allimax Us 500 W Superior StUnit 2205/#2205Chicago, IL 60654-8150United States [email protected] WARNING LETTER Date:      January 12, […]
January 28, 2021

AusarHerbs – 610976 – 01/12/2021

Product: DrugsFood & Beverages Date:   January 12, 2021 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that […]
January 28, 2021

Information about Nitrosamine Impurities in Medications

A. FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure […]
January 28, 2021

Division of Oncology 2 (DO2)

The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: […]
January 28, 2021

Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling

Summary Company Announcement Date: January 27, 2021 FDA Publish Date: January 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Meitheal […]
January 27, 2021

Office of Prescription Drug Promotion (OPDP) Metrics

Number of core initial promotional campaign material reviews completed in the month Dictionary: “Launch” materials are the initial promotional materials that companies disseminate to healthcare professionals […]
January 27, 2021

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin Due to Possible Microbial Contamination

Summary Company Announcement Date: August 29, 2018 FDA Publish Date: March 19, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Possible Microbial […]
January 27, 2021

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Summary Company Announcement Date: March 15, 2019 FDA Publish Date: March 15, 2019 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Presence of […]
January 27, 2021

Is it legal for me to personally import drugs?

En Español In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other […]
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