Archive | July, 2010

Coumadin 1 mg Tablet Blister Packs: Recall

14. July 2010

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Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.

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Arava (leflunomide): Boxed Warning – Risk of Severe Liver Injury

13. July 2010

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Warning highlights the risk of severe liver injury and how this risk may be reduced.

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Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

9. July 2010

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Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.

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Que She Herbal Supplement: Undeclared Drug Ingredients

8. July 2010

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Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.

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McNeil Consumer Healthcare Over-The-Counter Products: Recall

7. July 2010

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UPDATED 07/08/2010. Recall expanded to include lots of 21 products of Benadryl, Tylenol, Childrens Tylenol, Tylenol PM and Motrin.

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Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall

2. July 2010

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The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.

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LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

2. July 2010

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A power supply assembly failure can result in the inability to deliver defibrillation therapy.

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