July 17, 2009 – All Nuby Gel Filled Teethers, manufactured and distributed by Luv N’ Care, Ltd of Monroe, Louisiana, are being recalled nationwide. These products have been found to contain Bacillus subtilis and Bacillus circulans in the gel. These bacteria generally do not cause illness. However, if the teether is punctured and the liquid from the teether is ingested, the bacteria can affect children with weakened immune systems, causing stomach pain, vomiting, and diarrhea. If you have Nuby Gel Filled Teethers and Cottontails and Playschool Teethers with any of the UPC Codes listed below, stop using them immediately, discard them or return them to the place of purchase for a full refund.
The recall includes the following products:
UPC code Brand Name
48526-00451 Nûby
48526-00452 Nûby
48526-00453 Nûby
48526-00454 Nûby
48526-00455 Nûby
48526-00459 Nûby
48526-00467 Nûby
48526-00472 Nûby
48526-00473 Nûby
48526-00482 Nûby
48526-00483 Nûby
48526-00487 Nûby
48526-00490 Nûby
48526-00519 Nûby
48526-00521 Nûby
41520-87115 Cottontails
50428-91511 Playschool
41520-91660 Cottontails
The firm voluntarily recalled the products after learning that samples of two lots collected by the Food and Drug Administration were found to contain Bacillus subtilis and Bacillus circulans, respectively in the gel. FDA has been apprised of this action.
No illnesses have been reported to date.
Product was distributed through retail outlets nationwide and has been found to be marketed on the internet. The products are packaged in a plastic bubble on a printed card and can be identified by the UPC Codes listed above.
The company has ceased production and distribution of the products and is notifying its distributors to return the product. Consumers are urged to return the product to the place of purchase for a full refund.
Consumers with questions may contact Joseph H. Hakim at the company at 1-800-256-2399 ext. 3106 between 8:00 AM and 5:00 PM Central time.
Adverse reactions experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: gov/MedWatch/getforms.htm”>www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178
