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

  • Triaminic Syrups and Theraflu Warming Liquids
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 diphenhydramine which are required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.
Remedy:
Refund
Repair
Recall Date:
January 31, 2013
Units:
About 2.3 Million
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

In Conjunction With:
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.

Remedy:

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

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.

Sold At:
Food, drug, mass merchandise and club stores nationwide between May 2010 and December 2011 for about $5.
Manufactured In:
U.S.A.
Recall number:
13-114

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The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risk of injury associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product-related incidents cost the nation more than $1 trillion annually. Since the CPSC was established more than 50 years ago, it has worked to ensure the safety of consumer products, which has contributed to a decline in injuries associated with these products.

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