After the Food and Drug Administration (FDA) approves a product and it is on
the market, FDA continues to monitor unexpected and undesirable side effects
(adverse events) of that product.
Health care professionals and consumers may
report side effects, product quality problems, product use errors, or
therapeutic failure with the use of medical products to FDA's MedWatch Adverse
Event Reporting program either online, by regular mail, by fax, or by phone.
- Online
- Regular Mail: Use postage-paid FDA
form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD
20852-9787.- Fax: 1-800-FDA-0178
- Phone: 1-800-332-1088
MedWatch reports can signal a safety problem and lead to an FDA action to
protect the public from harm, serious illness, or even death.Recall: Nuby Gel Filled, Cottontails, and Playschool
Certain teethers made by Luv N’ Care LTD have been recalled because they
Teethers
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.
Thursday, August 13, 2009
FDA Recall List: Baby Products
This just in from the Food and Drug Administration:
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