The U.S. Food and Drug Administration (FDA) is urging consumers to not purchase or use certain Luv N’ Care Limited Gel-Filled Teethers, which the FDA found contained bacteria; a nationwide recall is underway. The FDA found Bacillus subtilis and Bacillus circulans in gel from samples it collected from two lots.
Luv N’ Care Ltd. of Monroe, Louisiana has initiated the recall of its gel-filled teethers with the brand names “Nuby,” “Cottontails,” and “Playschool.” The agency explained that while the bacteria found in the recalled teethers 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 should the recalled Luv N’ Care teether become punctured and the children ingest the liquid gel.
The FDA is advising consumers in possession of the recalled teethers containing the following brand names and UPCs to immediately stop using them and discard or return them to the place of purchase for a full refund.
Brand name Nuby with UPCs: 48526-00451, 48526-00452, 48526-00453, 48526-00454, 48526-00455, 48526-00459, 48526-00467, 48526-00472, 48526-00473, 48526-00482, 48526-00483, 48526-00487, 48526-00490, 48526-00519, and 48526-00521.
Brand Name Cottontails with UPCs: 41520-87115 and 50428-91511.
Brand name Playschool with UPCs: 41520-91660.
Luv N’ Care Ltd. distributed the recalled teethers 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 here.
The FDA announced that no illnesses have been reported to date and Luv N’ Care Ltd. 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 toll-free at 1-800-256-2399 ext. 3106 between 8:00 a.m. and 5:00 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 at: www.fda.gov/medwatch/report.htm; via Fax at 1-800-FDA-0178; or by regular mail (using the postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm) to MedWatch, 5600 Fishers Lane, Rockville, Maryland, 20852-9787.
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