Drug Recalls
Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter
FOR IMMEDIATE RELEASE - SCHAUMBURG, IL – May 28, 2024 – Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product.
Food & Beverage Recalls
Fresh Start Produce Sales Initiates Recall of Whole Cucumbers Because of Possible Health Risk
FOR IMMEDIATE RELEASE- May 31, 2024 – Fresh Start Produce Sales Inc. of Delray, Florida, is recalling whole cucumbers shipped to certain states from May 17th through May 21st, 2024, due to the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The recalled cucumbers were shipped in bulk cartons from May 17th through May 21st, 2024, directly to retail distribution centers, wholesalers, and food service distributors in Alabama, Florida, Georgia, Illinois, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, and West Virginia.
The recalled cucumbers are dark green, approximately 1.5 - 2.0 inches in diameter, and 5-9 inches long. Mini cucumbers and English cucumbers are not included in this recall.
The recall was initiated after the Pennsylvania Department of Agriculture informed the company that a product sample tested positive for the bacteria. The FDA is conducting whole genome sequencing to determine if this sample is related to an ongoing Salmonella outbreak investigation.
Medical Device Recalls
Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction
On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate. It has also been reported that the main tube is susceptible to tearing. The primary health and safety risks due to these defects include increased risk of patient re-intubation, delay in case and/or treatment, respiratory distress from loss of ventilation, uncontrolled loss of airway gases, and, if the device comes apart during use, partial or total airway obstruction and choking. These may lead to inefficient ventilation or failure to ventilate and oxygenate, hypoxemia, carbon dioxide retention, acidemia, organ ischemia, cardiorespiratory arrest, regurgitation and aspiration of gastric contents, ventilator associated pneumonia, bradycardia, cardiac arrest, bleeding, tissue damage, and organ damage.
Consumers who have SubG Endotracheal Tube with Subglottic Suction should stop using and discard the device. No product is to be returned to Medline.
Recalled SubG Endotracheal Tube with Subglottic Suction were manufactured from March 01, 2021 to January 01, 2024 and distributed from March 01, 2021 to February 20, 2024.
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