FDA Urges Consumers Not To Purchase Or Use Certain Gel-Filled Teethers

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Jul 2009 - 1:00 PDT

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Luv N' Care Ltd. of Monroe, La., is initiating a nationwide recall of gel-filled teethers with the brand names "Nuby," "Cottontails" and "Playschool," because the liquid inside the gel-filled teethers has been found to contain Bacillus subtilis and Bacillus circulans bacteria in the gel.

Although these bacteria generally do not cause illness in adults, infants and children with weakened immune systems can experience stomach pain, vomiting, diarrhea, and uncommonly more serious disease, if the teether becomes punctured and they ingest the liquid gel.

Consumers who have teethers with the brand names and UPC Codes listed below should immediately stop using them and discard or return them to the place of purchase for a full refund.

The recall includes the following products:

UPC code - Brand Name

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 firm voluntarily recalled the products after learning that the FDA found Bacillus subtilis and Bacillus circulans in the gel in samples from two lots collected by the FDA.

No illnesses have been reported to date.

The company distributed the products through retail outlets nationwide. The products have also 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 products. Consumers are urged to return the products to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-800-256-2399 ext. 3106 between 8 a.m. and 5 p.m. 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: http://www.fda.gov/medwatch/report.htm

- Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

- Fax: 1-800-FDA-0178

Source
U.S. Food and Drug Administration

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