The Recall Desk
HighCPSC·13114·Announced 2013-01-31

Triaminic and Theraflu Syrups Recalled for Child-Resistant Cap Failure

Novartis is recalling Triaminic and Theraflu syrups because child-resistant caps may fail, posing a poisoning risk to children.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (poisoning) where injury has been reported (one child required medical attention), but no deaths or serious injuries are documented, fitting the High severity criteria.

Plain-English summary

Novartis Consumer Health Inc. is recalling approximately 2.3 million units of Triaminic® Syrups and Theraflu Warming Relief® Syrups. The recall involves 24 types of these cough, cold, and fever products sold nationwide between May 2010 and December 2011 for about $5 each. The products contain acetaminophen and diphenhydramine, which are required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.

The recall is due to a defect where the child-resistant caps can fail to function properly, allowing a child to remove the cap while the tamper-evident seal remains in place. This poses a risk of unintentional ingestion and poisoning. 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.

Consumers should immediately stop using the recalled product and contact Novartis for instructions on how to return it for a full refund. Lot numbers and National Drug Codes (NDC) can be found on the product packaging or at www.novartisOTC.com. Consumers can also contact Novartis Consumer Healthcare toll-free at (866) 553-6742 from 8 a.m. to midnight ET, Monday through Saturday.

The recalled product

Product
Triaminic® Syrups and Theraflu Warming Relief® Syrups
Manufacturer
Novartis Consumer Health Inc., of Parsippany, NJ
Category
Drug — Over-the-Counter Medication
Hazard

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · poisoning

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