Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its <"http://www.yourlawyer.com/practice_areas/defective_drugs">Hyland’s Teething Tablets, the FDA just announced. The FDA is conducting an investigation of Hylandâ€™s manufacturing facility.
Hylandâ€™s Teething Tablets are manufactured in the United States and distributed throughout North America. The Hylandâ€™s Teething Tablets UPC codes included in the recall are:
â€¢ Hylandâ€™s Teething Tablets, 125 tablets, UPC # 3 54973 75041
â€¢ Hylandâ€™s Teething Tablets, 250 tablets, UPC # 3 54973 75042
â€¢ Hylandâ€™s Teething Tablets, 125 tablets, UPC # 3 54973 75066
â€¢ Hylandâ€™s Teething Tablets, 50 tablets, UPC # 3 54973 75044
â€¢ Hylandâ€™s Teething Tablets, 145 tablets, UPC # 3 54973 75121
â€¢ Hylandâ€™s Teething Tablets, Clip Strip 6×125 tablets, UPC # 3 54973 35109
Adverse events have been reported; however, the FDA has said that a conclusive link to Teething Tablets has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hylandâ€™s Teething Tablets have a wide margin of safety that protects consumers from harm.
After in-depth analysis, a comprehensive review of the companyâ€™s adverse event report log, and more than 85 years of safe usage, the company is confident that Hylandâ€™s Teething Tablets are safe for infants and toddlers.
In addition to the product recall, Standard Homeopathic Company is refining its production, packaging, and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.
Consumers concerned with the productâ€™s safety may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets. Consumers with medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.