Archive for January 20th, 2012

Tysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.

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Price Chopper Supermarkets Recalls Shredded Taco Cheese

Price Chopper Supermarkets is issuing a voluntary recall on its Coyote Joes Shredded Taco Cheese 16 oz, UPC 41735-12509 with an expiration date of April 21, 2012 due to the possibility of shredded plastic fragments inside the packaging.

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FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).

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Perfect Image Solutions Topical Hair Regrowth Products: Recall – Unapproved Drugs, Risk of Health Hazards

Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.

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Vagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination

Possibility of an adverse reaction or unknown drug-drug interaction.

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Perfect Image Solutions, LLC Issues Voluntary Recall of Unapproved Product Due to Potential Health Risk

Perfect Image Solutions, LLC is voluntarily recalling all lots of Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL; Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL; Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL; Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL; and Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level. The products are deemed “unapproved new drugsâ€� under the law and U.S. Food and Drug Administration regulations and may present potential health hazards.

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Carefusion Provides Update on Voluntary Recall of Neurilogical Monitoring Software and Devices

CareFusion issued the following update regarding its voluntary recall of the Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. The FDA has classified this action as a Class I recall.

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JKS Wholesale SVCS, Allergy Alert On Undeclared Milk Allergens In “Torta de Pan” Date Code 02/15/2012

JKS Wholesale SVCS INC, of Beltsville, MD is recalling its 16 oz. packages of “Torta de Pan� because they may contain undeclared milk allergens. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Kradjian Imp Co Is Doing An Extended Recall Of Cedar Tree Brand Tresse Cheese And Cedar Tree Brand Shinglish Cheese Because Of Possible Health Risk

Kradjian Imp Co, Glendale, CA is recalling 231 Cases, 22Lb / Cs of Cedar Tree brand Tresse Cheese, 16 oz and Cedar Tree brand Shinglish cheese, 16 oz because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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