Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process

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 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, 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/recall9 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 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/medwatch10.

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.com11 or www.facebook.com/Hylands.Health.

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Kilosports Inc. Issues Voluntary Recall of Clomed

KiloSports Inc. of Phoenix, AZ is recalling 60 Count bottles of Clomed because it may contain an Aromatase Inhibitor. KiloSports Inc. has been informed by the US Food and Drug Administration (FDA) that adverse events associated with the use of Aromatase Inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. The FDA concludes that products containing aromatase inhibitors have a increased probability of developing adverse reactions in at risk consumers.

Clomed was distributed throughout the United States and could be purchased by consumers via retail stores, mail order and Internet Sales.

Clomed comes in plastic black bottles with black safety caps contains 60 Count white or clear capsules with the UPC Code (8 58515 00265 7 & 8 5851500096 7 ) All lot numbers are being affected by this voluntary recall.

KiloSports Inc. has received no reports of any adverse effects or Illness of any type since first marketing Clomed since 2005.

Consumers who have purchased Clomed are asked to return it to the place of purchase for a full refund. Consumers with any questions may contact the company at 1.480.545.3489 9AM – 5PM Monday - Friday.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.

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Teva Animal Health, Inc. expands a voluntary nationwide recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials

Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

Ketamine Hydrochloride is a rapid acting, non-narcotic, non-barbiturate agent for anesthetic use in cats and for restraint in subhuman primates. This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

Consumers with questions may contact 800-759-3664 from 8:00am – 5:00pm CST Monday-Friday.

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FDA Alerts Consumers to Recall of Water-Based Face Paints

The Food and Drug Administration is advising consumers to stop using certain cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide.

The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory.

The following Face Paints manufactured by Shanghai Color Art Stationery Company Limited, Shanghai, China, are being voluntarily recalled by Fun Express Inc., a wholly-owned subsidiary of Oriental Trading Co.:

Item Number	Product Description	Universal Product Code (UPC)
85/2077	Blue Face Paint	8 8760048110 7
85/2078	Purple Face Paint	8 8760048112 1
85/2079	Red Face Paint	8 8760048114 5
85/2080	Orange Face Paint	8 8760048116 9
85/2081	Black Face Paint	8 8760048118 3
85/2082	Green Face Paint	8 8760048120 6

Fun Express Inc. is recalling the face paints from the market and FDA advises consumers to stop use of these products and discard them or return them to the retailer.

The FDA encourages consumers and health care providers to report any adverse events from face paints to the FDA as well as to state and local health authorities.

Adverse events and product quality problems can be reported to FDA's MedWatch Adverse Event Reporting program:
online at www.fda.gov/MedWatch/report.htm
by calling 1-800-FDA-1088
by returning the postage-paid FDA form 3500 (which may be downloaded from www.fda.gov/MedWatch/getforms.htm)
by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
by fax 1-800-FDA-0178

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