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

Reported: January 31, 2013 Initiated: January 31, 2013 #13114

Product 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.

Reason for Recall

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

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

Details

Units Affected
About 2.3 Million
Official Source
https://www.cpsc.gov/Recalls/2013/Triaminic-and-Theraflu-Products-Recalled

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Novartis Consumer Health Inc., of Parsippany, NJ. Units affected: About 2.3 Million.
Why was this product recalled? ▼
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.
What should consumers do? ▼
Consumers should immediately stop using the recalled product and contact Novartis for instructions on how to return the product for a full refund.
Which agency issued this recall? ▼
This recall was issued by the CPSC on January 31, 2013. Severity: Moderate. Recall number: 13114.

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