Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication – FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems

[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…

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#…