Recalls 1606 articles

Ice cream, sherbets recalled, may contain metal bits

H-E-B is recalling certain flavors and container sizes of EconoMax and Hill Country Fare ice cream and Creamy Creations sherbet because they may contain bits of metal from a broken part found in processing equipment during routine maintenance. The affected ice creams and sherbets were distributed to H-E-B stores in Texas and Mexico. To date, no injuries have been reported due to this incident. H-E-B says it has already removed all related products from its store shelves and intends to have a new shipment to replace them as soon as possible. The recall involves 4-quart, 4.5-quart, quart, and 56-ounce cartons ... Read More

Shave cream, acne products recalled due to potential contamination

Topical shave creams, acne products and pain gels manufactured by Shadow Holdings are being recalled because they may be contaminated with bacteria that could lead to serious infections in people with compromised immune systems. To date, no reports of adverse events have been associated with use of these products. Affected products include all lots within expiration date of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit. Herb-X Solutions X-Jow Pain Gel is an external analgesic, and is packaged in 4 oz. and 8 oz. bottles. ... Read More

Medtronic recalls revascularization device due to defect

Medtronic is recalling the MindFrame Capture LP revascularization device used to during procedures to treat strokes because the delivery wire may break or separate during use, leaving the clot retriever inside the patient’s bloodstream. This, or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death. The MindFrame Capture LP revascularization device used to restore blood flow or remove blood clots within in a blood vessel in the brain during an acute ischemic stoke in patients ineligible for or who fail intravenous plasminogen activator (IV ... Read More

Cardiac support device recalled due to malfunction

Abbott is recalling nearly 5,000 HeartMate 3 Left Ventricular Assist Systems that provide cardiac support to critically ill patients due to a potential malfunction that could reduce the action of the pump and pose serious adverse events to patients including blood clots and death. The HeartMate 3 Left Ventricular Assist System helps deliver blood from the heart to the rest of the body. It is used for the short-term support of patients who are at risk of death from end-stage left ventricular heart failure, such as patients awaiting a heart transplant. The system includes a blood pump that is implanted ... Read More

Homeopathic products recalled due to quality concerns

MBI Distributing Inc., is recalling several of its homeopathic drug products used to treat a variety of ailments from colic to cough because they were found to be manufactured without adequate controls to ensure the products’ strength, quality and purity. Use of these products could cause health problems especially in vulnerable patients, like the infants and children for which many of the products are intended. To date, MBI Distributing has not received any reports of adverse events related to this recall. Products affected by the recall include all lots of MBI Distributing Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, ... Read More

Fiat-Chrysler Recalls Nearly 5 Million Vehicles For Cruise-Control Glitch

Fiat-Chrysler is recalling nearly 5 million U.S. vehicles to repair a software glitch that could prevent drivers from canceling the cruise control. The problem affects about 4.8 million Fiat-Chrysler cars, minivans, SUVs, and pickup trucks from model-year 2014 to 2018. According to the automaker, “a driver could be unable to cancel cruise-control” if the cruise control system accelerates at the same time a “short-circuit in a specific electrical network” occurs. Normally drivers disengage cruise control by tapping the brake or hitting the cruise-control on-off switch, but both methods can stop working if the glitch occurs. The National Highway Traffic Safety ... Read More

FDA recalls supplements containing illegal prescription drugs

Shoreside Enterprises Inc., is recalling two dietary supplements promoted for male sexual enhancement after an analysis conducted by the Food and Drug Administration (FDA) revealed the products contained undeclared pharmaceutical drugs. The affected supplements – 7K and Poseidon 4500/Extreme 1000 mg  – contain sildenafil and/or tadalafil, the active ingredients in the prescription erectile dysfunction drugs Viagra and Cialis, respectively. Not only does the presence of these drugs in the dietary supplements render them unapproved drugs for which the safety and efficacy cannot be established, they also pose health risks to some people. Sildenafil and tadalfil may interact with nitrates found ... Read More

Lawmaker Questions FDA’s Handling of Egg Recall

A multistate outbreak of Salmonella poisoning linked to eggs and the weak response of federal regulators has Representative Rosa DeLauro (D-Conn.) concerned and full of questions. On May 21, Rep. DeLauro sent a letter to U.S. Food and Drug Administration (FDA) Administrator Scott Gottlieb seeking more information about what steps the agency has taken in response to the Salmonella outbreak, which has sickened at least 35 people in 11 states. Eleven of the sickened people have been hospitalized with more severe infections. The problem first came to light on April 13, when the FDA announced a recall of more than ... Read More

Apotex recalls combination antibiotic injection

Apotex Corp. is recalling 36 lots of the injectable antibiotics Peperacillin and Tazobactam after finding that they contain elevated levels of impurities that may decrease their potency. The product is manufactured by Hospira Inc., a Pfizer Company, and distributed in the U.S. by Apotex Corp. Decreased potency of Peperacillin and Tazobactam could result in worsening of the infection being treated and under extreme circumstances lead to serious conditions depending on the severity of the patient’s illness. Elevated levels of impurities may result in various toxicities, such as liver, renal and hematological toxicities. To date, the company has received no reports ... Read More

Resuscitation device recalled due to design error

Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in product design that may make it difficult or unable to disconnect the mask from the elbow of the resuscitator. This could cause a delay in or an inability to provide necessary ventilation to the patient and potentially result in serious patient injury, including death. The Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit are manual resuscitation devices that are used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot adequately breathe on their ... Read More