Summary Company Announcement Date: December 02, 2020 FDA Publish Date: December 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Burkholderia cepecia contamination. Company Name: MPM Medical, LLC Brand Name: Brand Name(s) MPM Medical Product Description: Product Description Regenecare HA Topical Anesthetic Hydrogel Company Announcement Mesquite, TX MPM Medical is voluntarily recalling one…
Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown 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 Products Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Product Code: 35700ABB and 35700BAX Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)…
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…
Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error
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 Cook Medical Fixed Core Wire Guide Affected Models: o Model TSCF-35-260-3 Lots: Manufacturing Dates: August 24, 2020 Distribution Dates: September 09, 2020 Devices Recalled in the U.S.:…
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…
Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use
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 Trevo XP ProVue Retriever Catalog Numbers and Lot Numbers: Full List of Affected Devices Manufacturing Dates: July 22, 2019 to September 9, 2019 Distribution Dates: September 18,…
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…