Archive | July, 2009

POWERSAIL Coronary Dilatation Catheters

30. July 2009

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Class 1 recall due to damage to distal catheter shaft and risk of air embolism and myocardial infarction.

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Colchicine (marketed as Colcrys)

30. July 2009

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Two previously uncharacterized safety concerns associated with the use of colchicine.

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Body Building Products (Marketed as Containing Steroids or Steroid-like Substances)

28. July 2009

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Products are unapproved drugs and associated with serious risks of liver injury, stroke.

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Electronic Cigarettes

22. July 2009

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FDA analysis has found carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

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Nuby Gel Filled, Cottontails, and Playschool Teethers

18. July 2009

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Nationwide recall due to potential bacterial contamination, placing children with weakened immune systems at risk of harm.

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Propofol Injectable Emulsion, 10 mg/mL 100 mL vials

17. July 2009

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Recall due to presence of elevated endotoxin levels in some vials.

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Weight Loss Products by Young You Corporation

17. July 2009

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Products recalled due to an undeclared drug ingredient which may present a significant health risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 07/17/2009

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Omalizumab (marketed as Xolair) – Early Communication about an Ongoing Safety Review

16. July 2009

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FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events.

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Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac

16. July 2009

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Products recalled because samples were found to contain undeclared drug ingredients.

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Concentrated Acetaminophen Drops

15. July 2009

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Nationwide voluntary recall of all lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops in 16 ounce (473 ml) bulk containers, a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.

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