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…

Filling in Wrinkles Safely

Image CaptionBeing injected with dermal fillers poses some risks. The most common side effects include: bruising, redness, swelling, pain, and itching. Additional side effects include: infections, lumps and bumps, and discoloration or change in pigmentation. Español These days, people across the country are seeking treatments to smooth smile lines and crow’s feet and to plump…

Protect Your Family From Fraudulent Flu Products

Image The fall and winter flu season may bring out dishonest sellers hawking fraudulent products to unsuspecting consumers, who are already concerned about protecting themselves from coronavirus disease 2019 (COVID-19) and other infectious diseases. Some of these sellers offer unproven products that claim to prevent, mitigate, treat, or cure the flu even though they have…

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…

Coronavirus Disease 2019 Testing Basics

Español 简体中文 한국어 Tagalog Việt You’ve probably heard a lot about coronavirus disease (COVID-19) testing recently. If you think you have COVID-19 and need a test, contact your health care provider, local pharmacy, or local health department immediately. The FDA has been working around the clock to increase the availability of critical medical products, including…

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….