Triaminic and Theraflu Products Recalled Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning

WASHINGTON, Jan. 31, 2013 /PRNewswire-USNewswire/ -- Consumers should stop using this product, which is being recalled voluntarily, unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

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Recall Summary

Name of product: Triaminic® Syrups and Theraflu Warming Relief® Syrups

Hazard: These child-resistant caps can fail to function properly and enable the cap to be removed by a child with the tamper-evident seal in place, posing a risk of unintentional ingestion and poisoning. These products contain acetaminophen and in some cases diphenhydramine which are required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.

Remedy: Repair, Refund

Consumer Contact:  Novartis Consumer Healthcare toll-free at (866) 553-6742 from 8 a.m. to midnight ET, Monday through Saturday, or online at www.novartisOTC.com for more information.

Recall Details

Units: About 2.3 Million

Description: This recall involves Triaminic® Syrups and Theraflu Warming Relief® Syrups for coughs, colds and fevers. There are 24 types of these two products included in the recall. A complete list of products, lot numbers and National Drug Codes (NDC) can be found at www.novartisOTC.com. Lot numbers are located on the bottom panel of the box and on the left side of the label on the bottle. The NDC number is located on the upper right corner of the front panel of the Triaminic Syrups box and the upper left corner of the Theraflu Warming Relief Syrups bottle.

Incidents/Injuries: The firm has received 12 reports of children unscrewing the locked caps, including four reports of children ingesting the product. One child required medical attention.

Remedy: Consumers should immediately stop using the recalled product and contact Novartis for instructions on how to return the product for a full refund.

Sold at: Food, drug, mass merchandise and club stores nationwide between May 2010 and December 2011 for about $5.

Manufacturer: Novartis Consumer Health Inc., of Parsippany, NJ

Manufactured in: U.S.A.

The U.S. Consumer Product Safety Commission (CPSC) is still interested in receiving incident or injury reports that are either directly related to this product recall or involve a different hazard with the same product. Please tell us about your experience with the product on SaferProducts.gov.

CPSC is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of consumer products under the agency's jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $900 billion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. CPSC's work to ensure the safety of consumer products—such as toys, cribs, power tools, cigarette lighters, and household chemicals—contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 30 years.

Under federal law, it is illegal to attempt to sell or resell this or any other recalled product.

To report a dangerous product or a product-related injury, go online to: SaferProducts.gov, call CPSC's Hotline at (800) 638-2772 or teletypewriter at (301) 595-7054 for the hearing and speech impaired.  Consumers can obtain this news release and product safety information at www.cpsc.gov

CPSC Consumer Information Hotline
Contact us at this toll-free number if you have questions about a recall:
800-638-2772 (TTY 301-595-7054)
Times: 8 a.m.5:30 p.m. ET; Messages can be left anytime
Call to get product safety and other agency information and to report unsafe products.

Media Contact
Please use the phone numbers below for all media requests.
Phone: (301) 504-7908
Spanish: (301) 504-7800

SOURCE U.S. Consumer Product Safety Commission



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