Archive | December, 2009

Nzu, Traditional Remedy for Morning Sickness

31. December 2009

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Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic

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Nzu, Traditional Remedy for Morning Sickness

31. December 2009

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Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic

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Thermoflect Blankets and product line – Recall

28. December 2009

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FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments

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Thermoflect Blankets and product line – Recall

28. December 2009

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FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments

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Cordis CROSSOVER Sheath Introducer – Recall

23. December 2009

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[UPDATED 12/23/2009] Recall classified as Class I. Nationwide recall due to stretching or fracture of the sheath during use.

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Cordis CROSSOVER Sheath Introducer – Recall

23. December 2009

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[UPDATED 12/23/2009] Recall classified as Class I. Nationwide recall due to stretching or fracture of the sheath during use.

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Steris System 1 Processor: FDA Notice and Recommendations

17. December 2009

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[UPDATED 12/17/2009] List of alternative products added. Unapproved device with potential for improper sterilization and disinfection.

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Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels – Incorrect Packaging

9. December 2009

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One lot recalled because labeling on the foil blister card of certain packages were printed with the label reversed, and consumers may not be aware of the warnings of an antihistamine that could cause drowsiness.

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CT Brain Perfusion Scans Safety Investigation: Initial Notification

7. December 2009

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[UPDATED 12/07/2009] FDA identified at least 50 additional patients exposed to excess radiation; interim recommendations for imaging facilities provided.

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Voltaren Gel (diclofenac sodium topical gel) 1% – Hepatic Effects Labeling Changes

4. December 2009

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Cases of drug-induced hepatotoxicity reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.

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