Image Español You have flu symptoms, so you’ve been getting some relief by taking a cough and flu medicine every few hours. Late in the day, you have a headache and think about grabbing a couple of acetaminophen tablets (Tylenol, paracetamol and panadol) to treat the pain. Stop right there. You might not realize that…
Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist
Please be aware, this recall is a correction, not a product removal. 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 Product Names: Atrium Express Dry Suction Dry Seal Chest Drain Product Codes: CAC Model Numbers:…
Former Employee of Medical Device Manufacturer Sentenced for Forging Two FDA Letters that Led to Illegal Sale of Medical Devices
Department of JusticeU.S. Attorney’s OfficeEastern District of Pennsylvania FOR IMMEDIATE RELEASEWednesday, January 24, 2024 The Justice Department announced today that a federal judge sentenced a Philadelphia-area man to prison yesterday for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance. Peter Stoll III, 35, pleaded guilty last year to one felony count…
Byrne Dairy Recalls Mighty Fine Chocolate Ice Cream in Half Gallons Dated 10/4/2024 Due to Undeclared Peanuts
Summary Company Announcement Date: January 30, 2024 FDA Publish Date: January 30, 2024 Product Type: Food & Beverages Ice Cream/Frozen Dairy Allergens Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: Byrne Dairy Inc. Brand Name: Brand Name(s) Byrne Dairy Product Description: Product Description Mighty Fine Chocolate Ice cream Company Announcement Byrne Dairy, Inc….
Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release
Summary Company Announcement Date: January 19, 2024 FDA Publish Date: January 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety Potential Safety Concerns Company Name: Kilitch Healthcare India Limited Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Lubricant Eye Drops & Multi-Symptom Eye Drops Company Announcement The…
Al Amir Fresh Foods Issues Allergy Alert on Undeclared Sesame in Hummus Dip Products and Undeclared Milk in Tzatziki Cucumber Yogurt
Summary Company Announcement Date: January 20, 2024 FDA Publish Date: January 20, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Sesame & Milk Company Name: Al Amir Fresh Foods Brand Name: Brand Name(s) Al Amir Fresh Foods Product Description: Product Description Hummus Dip & Tzatziki Cucumber Yogurt Company Announcement Al…
Prolia (denosumab): Drug Safety Communication – FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
[Posted 01/19/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Nephrology, Pharmacy ISSUE: Based on a completed FDA review of available information, FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis. Severe hypocalcemia appears to be more…
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
Date Issued: January 18, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about AirFit and AirTouch mask models recalled by ResMed Ltd (ResMed). These masks are used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP)….
Whitley’s Peanut Factory Issues an Allergy Alert on Undeclared Peanuts, Milk, Soy, Wheat, and Sesame for Limited Units of Deluxe Nut Mix 12oz (340g)
Summary Company Announcement Date: January 18, 2024 FDA Publish Date: January 18, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Allergens – Peanuts, Milk, Soy, Wheat, and Sesame Company Name: Whitley’s Peanut Factory Brand Name: Brand Name(s) Whitley’s Peanut Factory Product Description: Product Description Deluxe Nut Mix Company Announcement Whitley’s…
Hans Kissle Issues Allergy Alert on Undeclared Soy & Egg in “Hans Kissle Mexican Style Quinoa Salad”
Summary Company Announcement Date: January 18, 2024 FDA Publish Date: January 18, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Allergens – Egg, Soy Company Name: Hans Kissle Brand Name: Brand Name(s) Product Description: Product Description Mexican Style Quinoa Salad Company Announcement Hans Kissle of Haverhill, MA, is recalling its…