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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskCPSC
Medications & Supplements/Over-the-Counter

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

Agency Publication Date: January 31, 2013
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Summary

Novartis Consumer Health is recalling approximately 2.3 million units of Triaminic Syrups and Theraflu Warming Relief Syrups (acetaminophen and diphenhydramine) used for coughs, colds, and fevers. The child-resistant caps on these bottles can fail, allowing children to remove them even with the tamper-evident seal in place. The company has received 12 reports of children unscrewing the caps, including four instances of ingestion, with one child requiring medical attention. These products were sold at food, drug, mass merchandise, and club stores nationwide between May 2010 and December 2011 for about $5. Consumers should immediately stop using the recalled syrups and contact Novartis for a full refund.

Risk

The faulty caps allow children to easily access medications containing acetaminophen and diphenhydramine, posing a serious risk of accidental ingestion and poisoning. Four children are reported to have ingested the product after opening the locked caps.

What You Should Do

  1. Immediately stop using the recalled Triaminic and Theraflu Warming Relief Syrups and keep them out of the reach of children.
  2. Identify if your product is affected by checking the National Drug Code (NDC) number, which is located on the upper right corner of the front panel of the Triaminic Syrups box or the upper left corner of the Theraflu Warming Relief Syrups bottle.
  3. Check the lot number located on the bottom panel of the box and on the left side of the label on the bottle. A complete list of the 24 affected product types, lot numbers, and NDC codes is available at www.novartisOTC.com.
  4. Contact Novartis Consumer Healthcare toll-free at (866) 553-6742 between 8 a.m. and midnight ET, Monday through Saturday, or visit www.novartisOTC.com for instructions on how to return the product for a full refund.
  5. For additional questions or to report further incidents, contact the CPSC Hotline at 800-638-2772.

Your Remedy Options

📋Refund, Repair

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

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.

Affected Products

Product: Triaminic Syrups
Model:
NDC (Upper right corner of front box panel)
Lot Numbers:
Bottom panel of box
Left side of bottle label
Date Ranges: Sold between May 2010 and December 2011
Product: Theraflu Warming Relief Syrups
Model:
NDC (Upper left corner of bottle)
Lot Numbers:
Bottom panel of box
Left side of bottle label
Date Ranges: Sold between May 2010 and December 2011

Product Images

Triaminic Syrups and Theraflu Warming Liquids

Triaminic Syrups and Theraflu Warming Liquids

Additional Information

Agency: Consumer Product Safety Commission (CPSC)
Recall ID: 13114
Status: Active
Manufacturer: Novartis Consumer Health Inc., of Parsippany, NJ
Sold By: Food, drug, mass merchandise and club stores nationwide between May 2010 and December 2011 for about $5.
Manufactured In: United States
Units Affected: About 2.3 Million
Distributed To: Nationwide
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.
Agency Last Updated: January 20, 2015

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: CPSC Notice · Raw API Response