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: High Frequency Transport Phasitron Breathing Circuit Kit (A50605-D) Product Codes: See Recall Database Entry Distribution Dates: June 9, 2023 to December 1, 2023 Devices Recalled…
Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil
Summary Company Announcement Date: February 02, 2024 FDA Publish Date: February 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Products contain undeclared Tadalafil and Nortadalafil Company Name: Today the World Brand Name: Brand Name(s) Sustain, Schwinnng Product Description: Product Description Sustain and Schwinnng brand male enhancement capsules Company Announcement FOR IMMEDIATE RELEASE…
Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix
Summary Company Announcement Date: January 28, 2024 FDA Publish Date: January 29, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tianeptine Company Name: Neptune Resources, LLC Brand Name: Brand Name(s) Neptune’s Fix Product Description: Product Description Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets Company Announcement Neptune Resources,…
Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes – FDA Safety Communication
Date Issued: February 2, 2024 The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use certain Cardinal Health Monoject luer-lock and enteral syringes. On February 2, 2024, Cardinal Health announced a recall for removal of all sizes of the following Cardinal Health brand Monoject syringes:…
Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps – Letter to Health Care Providers
November 20, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the FDA further evaluates this issue. In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health” Monoject syringes. These…
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene
Summary Company Announcement Date: February 01, 2024 FDA Publish Date: February 02, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Insight Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Company Announcement TARRYTOWN, N.Y.–(GLOBE NEWSWIRE)-February 1, 2024—Insight Pharmaceuticals, a Prestige…
Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error
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 (Include the following information) Product Names: ExcelsiusGPS Product Codes: OLO Part number: 6203.2100 Distribution Dates:…
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:…
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…
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…