Triaminic and Theraflu Products Recalled Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
Recall 13114 · Jan 31, 2013 · Novartis Consumer Health Inc.
2,300,000
units affected
2,300,000
units affected
Facts
- Recall number
- 13114
- Date
- Jan 31, 2013
- Company
- Novartis Consumer Health Inc.
- Units affected
- 2,300,000
- Product
- Triaminic® Syrups and Theraflu Warming Relief® Syrups
- Product type
- Other Drugs or Medications
- Remedy
- Refund, Repair
- Hazard
- Poisoning
The product
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.
What can happen
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.
The fix
Consumers should immediately stop using the recalled product and contact Novartis for instructions on how to return the product for a full refund.
Incidents and where it was sold
- Incidents
- 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.
Related pages
Questions and answers
What should I do with the recalled triaminic® syrups and theraflu warming relief® syrups?
Consumers should immediately stop using the recalled product and contact Novartis for instructions on how to return the product for a full refund.
What is the 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.
A recall means the maker found a safety problem and offers a free fix; it does not mean every unit has the problem. Units affected are as reported by the company. Popular models sell more and so have more recalls and complaints. Official public data; texts are shortened. Contact the company named above for the remedy.