Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements

Summary Company Announcement Date: November 22, 2020 FDA Publish Date: November 23, 2020 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Unapproved new drug Company Name: Fusion Health and Vitality LLC Brand Name: Brand Name(s) CORE, Immune Boost Product Description: Product Description CORE essential nutrients and Immune Boost Sublingual Vitamin D3 Company Announcement…

Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

Summary Company Announcement Date: November 19, 2020 FDA Publish Date: November 19, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Cross Contamination with Lidocaine Company Name: Fresenius Kabi USA Brand Name: Brand Name(s) Fresenius Kabi USA Product Description: Product Description Dexmedetomidine HCL in 0.9% Sodium Chloride Injection Company Announcement Fresenius Kabi USA is…

Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

Summary Company Announcement Date: November 09, 2020 FDA Publish Date: November 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description May be contaminated with Burkholderia lata Company Name: Lohxa, LLC Brand Name: Brand Name(s) Product Description: Product Description Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free Company Announcement Lohxa, LLC is voluntarily recalling…

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Rashkind Balloon Septostomy Catheter Lot Numbers: See the Recall database entries below for lot numbers Product Numbers: 008764, 007160, and 007161 Distribution Dates: May 28, 2018 to…

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 500 mg Company Announcement Nostrum Laboratories, Inc….

Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers

The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2…

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 750 mg Company Announcement Kansas City, Missouri,…

Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)

Summary Company Announcement Date: October 28, 2020 FDA Publish Date: October 29, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Deviations from the specified cleaning methods may impair infusion pump Company Name: Baxter International Inc. Brand Name: Brand Name(s) Sigma Spectrum Product Description: Product Description Infusion Pumps Company Announcement Baxter International Inc….