Los Angeles-based Standard Homeopathic Co. is recalling Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets because the U.S. Food & Drug Administration believes they’re hazardous to children.
The recall follows a conclusion by the FDA that the tablets contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products’ labels, according to Standard Homeopathic Co. Chairman and CEO J.P. Borneman.
The FDA believes that belladonna represents a serious health hazard to children and the effects of belladonna are unpredictable, Borneman said. The FDA has stated to the company, “There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it,” Borneman said.
The Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets have been used to provide temporary relief of teething symptoms in children. The recall includes all products retailers may have had in stock. Standard Homeopathic stopped making and shipping the medicines nationwide in October.
The recall ensures the removal of any possible remaining products that may be on store shelves, Borneman said. No other Standard Homeopathic Company or Hyland’s products are affected.
“We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested,” Borneman said.
“We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company. We have worked for 114 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
Standard Homeopathic Company is notifying its distributors and retailers by mail and is arranging for the return of all recalled products. Consumers who have products being recalled should discard the product.
Consumers with questions regarding the recall can call Standard Homeopathic Co. at (800) 991-3376 from 6 a.m.-4 p.m. weekdays. Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Reports can be made online at www.fda.gov/medwatch/report.htm The form to be mailed is available online at www.fda.gov/MedWatch/getforms.htm or by calling (800) 332-1088.
—City News Service