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Recalls 1288 articles

Antibiotic contaminated with potentially dangerous bacteria

antibiotics - vials, test tubes

Four lots of VistaPharm Inc.’s Nystatin Oral Suspension, an antibiotic used to treat fungal infections of the mouth including oral thrush, were found to be contaminated with the Burkholderia cepacia, a bacteria that can cause life threatening bloodstream infections, particularly in patients with weakened immune systems. B. cepacia infections can range from mild with no symptoms to severe with serious respiratory symptoms. It is especially dangerous to patients with cystic fibrosis. VistaPharm identified the source of the bacterial contamination as likely being purified water that was used to manufacture the drug products. Affected products include prescription only Nystatin Oral Suspension, ... Read More

Synergy Rx Pharmacy expands recall to include weight loss treatments, acne creams, chemical peels

acne

Synergy Rx Pharmacy has expanded a recall issued earlier this month on all lots of injectable Human Chorionic Gonadotropin (HCG), to include the following non-sterile products – Sublingual Tablets, HCG and HCG with resveratrol Human Chorionic Gonadoptropin), Non Sterile Dermatology creams all strengths (retinoic acid creams, hydroquinine creams, bleaching creams), Numbing Creams, acne creams, hair growth serums with minoxidil, betamethasone creams and Chemical Peels (salicylic acid peels, trichoracetic acid peels, glycolic acid peels, Jessners Peels, custom peels solutions). The recall was initiated due to lack of quality assurance. Administration of a drug product which does not meet the quality assurance ... Read More

Sexual enhancement dietary supplement recalled

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Organic Herbal Supply Inc., has issued a nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules after a Food and Drug Administration (FDA) analysis found that the dietary supplements contained a hidden drug ingredient, Tadalafil, the active ingredient in the prescription erectile dysfunction drug Cialis. This drug poses serious health risks to men who take nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The recall comes about two weeks after the FDA warned consumers not ... Read More

Sargento announces cheese recall expansion; severs ties with supplier Deutsch Kase Haus

Recall - cheese, Sargento, Longhorn colby - image by Sargento

Sargento Foods Inc., one of the largest cheesemakers in the nation, is expanding its initial recall of specialty Longhorn Colby cheese to include products packaged on the same lines as the cheeses recalled last week. The recalled cheese may be contaminated by Listeria monocytogenes, according to its supplier Deutsch Kase Haus. Sargento axed its relationship with the supplier due to the cheese recall. “Out of concern for the health and well-being of Sargento consumers, the company has also terminated its relationship with Deutsch Kase Haus, which supplied Sargento with the affected Longhorn Colby cheese,” the company stated in regards to ... Read More

Deutsch Kase Haus cheese recall expands to Biery Cheese and MDS Foods

Recall - cheese, Sargento, Longhorn colby - image by Sargento

February continues to rack up recalls as Deutsch Kase Haus, LLC, not only expands its original cheese recall, but also spurs Biery Cheese Company and MDS Foods Inc. to recall cheese supplied by it. The recalled cheese may be contaminated by Listeria monocytogenes – pathogenic organisms that can cause dangerous infections in young children, elderly people and those with weakened immune systems. According to the U.S. Food and Drug Administration (FDA), both companies were made aware this month that various types of Deutsch Kase Haus cheese are now subject to recall. MDS Foods Inc. is also recalling cheese that may ... Read More

Generic heartburn drug Protonix recalled

PPI proton pump inhibitor

Aurobindo Pharma Limited issued a recall for a generic version of the injectable heartburn treatment Protonix because some vials appeared to be discolored with a possible contaminant. Pantoprazole sodium is the active ingredient in Protonix. It is a class of acid-reducing drugs called proton pump inhibitors, or PPIs, which work by blocking the production of acid in the stomach. The medication is intended to be used short-term (7 to 10 days) in adult patients to treat esophageal reflux disease (GERD) and a history of erosive esophagitis. The recall affects 29,800 vials of pantoprazole sodium for injection, 40mg per vial, single dose. ... Read More

Dr. Reddy recalls generic version of Zyprexa for schizophrenia, bipolar disorder

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Pharmaceutical company Dr. Reddy’s Laboratories is recalling a generic version of the antipsychotic Zyprexa, known chemically as olanzapine, because the drug failed impurity and degradation specification testing. “Due to out-of-specification results for the Related Substance Compound C (Impurity 6 – N-Oxide at the 18 month stability station,” the recall noticed stated. The recall is classified as a Class III, which is a less serious type of recall reserved for products in which use of exposure is not likely to cause adverse health consequences. Olanzapine was approved by the Food and Drug Administration (FDA) in 2009 under the brand name Zyprexa. It ... Read More

FDA speeds up medical device recall notification in 2017

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The Food and Drug Administration (FDA) vowed that it will deliver warnings regarding recalled medical devices to the public in a more timely manner in 2017. The FDA defines a medical device recall as a correction or removal action to address a problem with a device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. When the FDA learns of a company’s recall or removal action regarding a medical device, the agency reviews the strategy the company poses ... Read More

Canadian baby food recall linked to cases of botulism food poisoning

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The Food and Drug Administration (FDA) is warning U.S. residents to be aware of a baby food recall issued by the Canadian Food Inspection Agency that has caused botulism food poisoning in some babies. The recall involves PC Organics baby foods that are only sold in Canada, but the FDA is concerned that some U.S. consumers may have purchased the products. The recall was initiated by Loblaw Companies Ltd. For PC Organics baby food pouches on Feb. 3, and expanded Feb. 8 to include more than 30 products in a variety of flavors. A full list of affected products, sizes ... Read More

Britax stroller recall encompasses more than 700K with dangerous fall hazard; 26 infants injured

Recall - strollers, Britax

More than 700,000 Britax B-Agile and BOB Motion strollers are now under recall by Britax and the U.S. Consumer Product Safety Commission (CPSC) following reports that its car seat may disengage and fall unexpectedly. The cause of the defect stems from a damaged receiver mount on the stroller, which was as a fall hazard to infants sitting in the car seat. According to the CPSC, the stroller recall involves all models and colors of the folding, single or double occupant Britax B-Agile and BOB Motion strollers. The recalled strollers should have Click & Go receiver mounts that are used to ... Read More