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Recalls 1578 articles

Blister packs of drugs recalled because they are not child resistant

Novartis and Sandoz are recalling several blister packaged prescription medications because they fail to meet child-resistant closure requirements as required by the Poison Prevention Package Act. The companies have received one report of a child consuming the antipsychotic haloperidol from a blister pack. The recall affects about 470,000 units and includes drugs packaged with 3 to 10 tablets per blister card. The blister packs were designed for use in hospitals but some were sent to retail pharmacies and were likely dispensed for in-home use. Novartis products affected by the recall include the anti-nausea drug Zofran ODT (ondansetron) 4mg and 8 ... Read More

Baby wash recalled due to infection risk

Bottles of Splish Splash Gentle Baby Wash made by Saje Natural Wellness are being recalled because they may be contaminated with the bacteria Pseudomonas aeruginosa, which poses an infection risk to consumers, particularly those with compromised immune systems. The recall affects 8.5 fluid ounce bottles of Saje Natural Wellness Splish Splash Gentle Baby Wash sold individually with the product SKU 700552, and the Lot Number 814020; and 1.7 fluid ounce bottles of Saje Natural Wellness Splish Splash Gentle Baby Wash sold in Wee and Well Gentle Baby Care Kits with the product SKU 700561 and the Lot Number 814020. The ... Read More

Salmonella Outbreak Linked to Melons Grows

A melon recall triggered by a multistate outbreak of Salmonella-related illnesses has been expanded to include 10 additional states, bringing the total number of states affected by the outbreak to 23, according to federal health officials. The U.S. Food and Drug Administration (FDA) said the recall encompasses pre-cut watermelon, honeydew melon, cantaloupe, and fruit salads containing one or more of those melons produced and distributed by Caito Foods of Indianapolis, Indiana. Alabama, Florida, Kansas, Maryland, Minnesota, Nebraska, North Dakota, South Dakota and Tennessee have been added to the list of states where the melon may be contaminated with salmonella, the ... Read More

Man Sickened by Salmonella Sues Melon Producer

An Indiana man who was hospitalized after eating melon contaminated with Salmonella is suing Caito Foods LLC, the producer of watermelon, cantaloupe, honeydew melon and other products that federal health officials say started a multistate outbreak of Salmonella illnesses. According to Food Safety News, Jacob Novero was infected with the Salmonella Adelaide strain linked to the contaminated products after buying and eating pre-cut fruit containing honeydew, cantaloupe, watermelon and blueberries produced by Caito Foods of Indianapolis. Mr. Novero bought the contaminated melon salad at a Walmart Supercenter in Noblesville, Indiana on May 12. He started feeling ill two days later ... Read More

73 people infected with Salmonella after eating Honey Smacks cereal

At least 73 people in 31 states have fallen ill from Salmonella infections and health authorities say the likely culprit is Kellogg’s Honey Smacks sweetened puffed wheat cereal. As a result, the Kellogg Company has recalled the cereal, which was distributed throughout the United States as well as Guam and Saipan, and internationally in Costa Rica, Guatemala, Mexico, the Caribbean and Tahiti. Consumers are urged not to eat any of the recalled Honey Smacks cereal. Affected products include Honey Smacks 15.3 oz boxes with the BEST if Used By Date listed as JUN 14, 2018 through JUN 14, 2019, and ... Read More

Maquet recalls heart pump due to design issue

Maquet Datascope Corp., is recalling more than 2,800 CARDIOSAVE Hybrid Intra-aortic Balloon Pumps (IABPs) distributed nationwide due to a design defect that can lead to pump malfunction, which could result in serious and potentially fatal health consequences to patients. The recall is listed as a Class I, which is the most serious type of recall. Use of these devices may cause serious injuries or death. CARDIOSAVE Hybrid Intra-aortic Balloon Pumps (IABPs) are cardiac-assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure. Marquet Datascope is recalling the ... Read More

Salmonella Outbreak Linked To Fresh Melon Products

At least 60 people eight states have been sickened by Salmonella linked to melon products made and distributed by Caito Foods of Indianapolis, Indiana, spurring a recall of fresh cut melon and fruit salads, federal health officials announced. The U.S. Centers for Disease Control and Prevention (CDC) said that the outbreak of Salmonella illnesses stems from fresh cut watermelon, honeydew melon, cantaloupe, and fruit medley mixtures containing any of these melon products. Caito Foods and others distributed the affected melon products to Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina and Ohio. People infected by the melon products, which are ... Read More

Hospira recalls opioid antidote

Hospira Inc., a Pfizer company, is recalling two lots of the opioid overdose reversal agent Naloxone Hydrochloride injection because there may be bits of particulate matter embedded and loose on the Carpuject Single-use cartridge syringe plunger. If the drug is administered to a patient, there is a chance the patient could experience a range of adverse events including local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. To date, Hospira has not received any reports of adverse events related to this issue. The recall affects lots 72680LL and 76510LL of Naloxone Hydrochloride ... Read More

Resuscitator bags recalled due to defect

SunMed Holdings LLC is recalling 18,808 units of STAT-Check and Medline resuscitator bags due to a defect that could render the device unable to deliver air to the patient, which could result in a delay in treatment and life-threatening health consequence. There have been no injuries related to this issue, to date. STAT-Check and Medline resuscitator bags are hand-held devices commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately. In the resuscitator bags affected by the recall, the patient port retaining ring may not fully seat, which may allow the patient port ... Read More

MedTronic heart device recalled due to electrical error

Medtronic is recalling more than 200,000 HeartWare Ventricular Assist Devices (HVAD systems) due to an electrical issue that could cause the device to disconnect from its electrical source, causing the pump to stop. This issue could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death. This recall is classified as a Class I recall, which is the most serious type of recall. Class I recalls are issued when use of a medical device may cause serious adverse events or death. The recall affects certain models ... Read More