English Actualización – 7 de febrero de 2023: El certificado de la Ley de estándares de calidad de mamografía (MQSA, por sus siglas en inglés) para Advanced Women Imaging (en inglés), en 6414 Bergenline Avenue, West New York, NJ (Bergenline) fue revocado hasta el 4 de enero de 2025. Actualmente, el centro no está acreditado…
Volt Candy Issues Voluntary Nationwide Recall of PrimeZen Black 6000 Capsules Due to Presence of Sildenafil and Tadalafil
Summary Company Announcement Date: February 13, 2023 FDA Publish Date: February 13, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil and sildenafil Company Name: Volt Candy Brand Name: Brand Name(s) Product Description: Product Description PrimeZEN Black 6000 male enhancement capsules Company Announcement FOR IMMEDIATE RELEASE – 2/13/2023 – Pomona,…
Universal Meditech Inc. Issues Nationwide Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
Summary Company Announcement Date: February 09, 2023 FDA Publish Date: February 10, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Products were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. Company Name: Universal Meditech Inc. Brand…
Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
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. The devices described in this recall notice are the same devices announced in the FDA safety communication Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests. Recalled Product Product Names:…
Nestlé Purina Petcare Company Voluntarily Recalls Purina Pro Plan Veterinary Diets El Elemental Dry Dog Food in the U.S. Due to Potentially Elevated Vitamin D
Summary Company Announcement Date: February 08, 2023 FDA Publish Date: February 08, 2023 Product Type: Animal & VeterinaryFood & Beverages Reason for Announcement: Recall Reason Description Potentially elevated Vitamin D Company Name: Nestle Purina PetCare Company Brand Name: Brand Name(s) Product Description: Product Description Veterinary Diets EL Elemental Dry Dog Food Company Announcement Nestlé Purina…
Pilgrim’s Roasted Nut’z Issues Allergy Alert on Undeclared Milk, Soy, Walnut in Snack Products
Summary Company Announcement Date: February 06, 2023 FDA Publish Date: February 08, 2023 Product Type: Food & Beverages Nuts & Nut Products Allergens Reason for Announcement: Recall Reason Description Undeclared milk, soy, walnut Company Name: Pilgrim’s Roasted Nut’ Z Brand Name: Brand Name(s) Pilgrim’s Roasted Nut’ Z Product Description: Product Description Chocolate Toffee Almonds, Crème…
Access to Naloxone Can Save a Life During an Opioid Overdose
Image Español Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the nation’s opioid crisis. Naloxone is a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose. Everyone who overdoses with opioids, whether with a prescribed medicine or…
2023 Safety Communications
The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2023 Safety Communications Content current as of: 02/07/2023 Article source: http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications
Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ
Update – February 7, 2023: The Mammography Quality Standards Act (MQSA) certificate for Advanced Women Imaging, located at 6414 Bergenline Avenue, West New York, NJ (Bergenline) was revoked until January 4, 2025. The facility is currently unaccredited, uncertified, and cannot legally perform mammography. Additionally, the FDA has identified two individuals that qualify as owners or…
Daiso Issues Allergy Alert for Prepackaged Snacks
Summary Company Announcement Date: February 03, 2023 FDA Publish Date: February 03, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Daiso California LLC Brand Name: Brand Name(s) Daiso California LLC Product Description: Product Description Powdered apple tea, crackers, cookies & candy Company Announcement Daiso California LLC of…