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FDA's MedWatch Safety Alerts: August 2009

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The risk: Salmonella can cause serious infections and even death in young children, frail or elderly people, and others with weakened immune systems.

Recommendations

  • Return the product to the store where you bought it for a refund.
  • Call Vital Pharmaceutical Inc. at 800-954-7904 or 954-641-0570 for more information.

 

Recall: Nuby Gel Filled, Cottontails, and Playschool Teethers

Certain teethers made by Luv N’ Care LTD have been recalled because they may contain harmful bacteria in the gel contained in the teether. The teethers affected have the following UPC codes and brand names:

48526-00451 Nuby

48526-00452 Nuby

48526-00453 Nuby

48526-00454 Nuby

48526-00455 Nuby

48526-00459 Nuby

48526-00467 Nuby

48526-00472 Nuby

48526-00473 Nuby

48526-00482 Nuby

48526-00483 Nuby

48526-00487 Nuby

48526-00490 Nuby

48526-00519 Nuby

48526-00521 Nuby

41520-87115 Cottontails

50428-91511 Playschool

41520-91660 Cottontails

The teethers were sold through retail stores nationwide and also on the Internet. They are packaged in a plastic bubble on a printed card.

The risk: The bacteria (Bacillus subtilis and Bacillus circulans) that have been found on the teethers can cause stomach pain, vomiting, and diarrhea in children with weakened immune systems if the teether is punctured and the liquid from the teether is swallowed.

Recommendations

  • Stop using the teethers immediately.
  • Throw the teethers out or return them to the store where you bought them for a refund.
  • Contact Luv N’ Care LTD at 1-800-256-2399 ext. 3106 for more information.

 

Early Communication on Safety of Xolair

FDA is evaluating safety findings known at this point from an ongoing study of Xolair (omalizumab). Xolair is approved for use by people 12 years of age and older with moderate to severe asthma who react to an airborne allergen year-round and whose symptoms are not controlled well with inhaled corticosteroids.

The risk: These interim findings suggest an increase in adverse events involving the blood vessels of the heart or brain (cardiovascular or cerebrovascular events) in people treated with Xolair compared to another group of people not given the drug.

This type of communication (early communication) is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion.

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