[Posted 04/24/2020] AUDIENCE: Consumer, Patient, Critical Care Medicine, Infectious Disease, Health Professional ISSUE: FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or…
CPAP Machine Cleaning: Ozone, UV Light Products Are Not FDA Approved
[embedded content] Español If you use a CPAP machine at night to help you breathe during sleep, you know it can be difficult to keep up a regular cleaning schedule. A dirty CPAP machine contaminated with germs like viruses and bacteria can make you sick. So automated machines advertised on TV that claim to clean…
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers
Summary Company Announcement Date: April 17, 2020 FDA Publish Date: April 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Out-of-Specification Results for High Molecular Weight Polymers Company Name: Braun Medical Inc Brand Name: Brand Name(s) Product Description: Product Description Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in…
Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753
Summary Company Announcement Date: April 20, 2020 FDA Publish Date: April 21, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Incorrect factory-set unit of measure Company Name: Trividia Health, Inc. Brand Name: Brand Name(s) TRUE METRIX Product Description: Product Description TRUE METRIX® AIR Blood Glucose Meter Company Announcement Trividia Health, Inc. today…
Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples
Summary Company Announcement Date: April 20, 2020 FDA Publish Date: April 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Particulate Matter Company Name: Fresenius Kabi USA, LLC Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2…
Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA
Summary Company Announcement Date: April 15, 2020 FDA Publish Date: April 15, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Amneal Pharmaceuticals, LLC Brand Name: Brand Name(s) Gemini Laboratories Product Description: Product Description Nizatidine Oral Solution 15 mg/mL Company Announcement Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily…
Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these…
International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A
Summary Company Announcement Date: January 10, 2018 FDA Publish Date: April 15, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Mislabeling Company Name: International Laboratories, LLC Brand Name: Brand Name(s) International Laboratories, LLC Product Description: Product Description Clopidogrel Tablets USP, 75 mg Company Announcement International Laboratories, LLC is voluntarily recalling Lot#…
Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications
Summary Company Announcement Date: April 15, 2020 FDA Publish Date: April 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to low out of specification dissolution results Company Name: Avet Pharmaceuticals Labs Inc. Brand Name: Brand Name(s) Product Description: Product Description Tetracycline HCl Capsules, 250mg and 500mg Company Announcement Avet Pharmaceuticals Inc….
Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial
Summary Company Announcement Date: January 08, 2018 FDA Publish Date: April 15, 2020 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Presence of Glass Particles in Vial Company Name: AuroMedics Pharma LLC Brand Name: Brand Name(s) AuroMedics Pharma LLC Product Description: Product Description Ampicillin and Sulbactam for Injection USP Company Announcement East…