from http://www.hylandsteething.com/recall/teething-tablet-recall.html
Working with FDA, Standard Homeopathic Company Voluntarily
Recalls Hyland’s Teething Tablets to Address Manufacturing Process
Los Angeles, October 23, 2010 – Standard Homeopathic Company, in
consultation with the U.S. Food and Drug Administration (FDA), is
voluntarily recalling its Hyland’s Teething Tablets. The company is
initiating this recall in an abundance of caution due to an FDA
investigation of its manufacturing facility. Hyland’s Teething Tablets
are manufactured in the United States and distributed throughout North
America.
The Hyland’s Teething Tablets UPC codes included in the recall are:
1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973
35109
Adverse events have been reported but the FDA has said that a conclusive
link 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,
Hyland’s Teething Tablets have a wide margin of safety that protects
consumers from harm.
After in-depth analysis, a comprehensive review of the company’s adverse
event report log, and more than 85 years of safe usage, the company is
confident that Hyland’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 that are concerned about the safety of the product 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.
No other Standard Homeopathic Company products are affected by this
recall.
Consumers who have 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.
With over 100 years of experience in providing families with access to
safe, natural, reliable medicines, Standard Homeopathic Company and its
division, Hyland’s, Inc., have many symptom fighting products consumers
have come to trust. For more information on their line of products,
visit www.hylands.com or
www.facebook.com/Hylands.Health.
About Standard Homeopathic Company
Standard Homeopathic Company develops and manufacturers lines of
homeopathic medicines, including its top-selling Hyland’s brand.
Hyland’s homeopathic formulas are manufactured with the highest quality
natural ingredients following the strictest standards of preparation.
With over a century of commitment, Standard Homeopathic Company’s
tradition of excellence consistently provides quality and integrity in
every product. From Hyland’s Teething Tablets to Hyland’s Calms Forté,
Standard Homeopathic Company cares for your family at every stage of
life. Consumers can trust Standard Homeopathic Company’s products to be
natural, gentle, effective and safe for the entire family.
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