Recall Alert: Triaminic® Syrups and Theraflu Warming Relief® Syrups

As flu season continues to sweep through the United States, ensuring the health and safety of your child is of paramount concern. We have an important recall alert to share with you regarding two common, over-the-counter cold and flu medicines.

In conjunction with the U.S. Consumer Product Safety Commission (CPSC), Novartis Consumer Health Inc. is voluntarily recalling specific lots of two of its over-the-counter treatment lines: Triaminic® Syrups and Theraflu Warming Relief® Syrups. The products are being removed from store shelves and should be discarded by consumers due to a defect with the child-resistant safety cap. The cap can be removed with the seal remaining in place, creating a risk of accidental ingestion and poisoning.

The Poison Prevention Packaging Act requires that all medications containing acetaminophen and diphenhydramine have tamper-resistant seals to prevent children from unintentionally drinking the medication. As the recalled units are not sealed properly, they pose a severe risk to children. Currently, the CPSC has received reports of 12 children unscrewing the failed caps, four ingesting the medicine, and one child requiring medical attention as a result.

The lots included in this recall were manufactured by Novartis prior to December 31, 2011. A total of 24 types of the two medications are recalled. They were sold at a variety of retailers, including drug, food, club, and mass merchandise stores from May 2010 to December 2011.

Identify the Product

To determine if your product was included in the recall, look at the bottom of the box, and on the left side of the bottle label. The lot number will be located in both places, while the National Drug Code will be printed on the upper left corner of the Theraflu box and the lower right corner of the Triaminic box.

Products affected by this recall include certain lots of the following:

  • Theraflu ® Warming Relief Flu and Sore Throat, 8.3 oz.
  • Theraflu® Daytime Warming Relief Severe Cold and Cough, 8.3 oz.
  • Theraflu® Daytime/Nighttime Severe Cold & Cough Value Pack
  • Theraflu® Nighttime Warming Relief Severe Cold and Cough, 8.3 oz.
  • Theraflu® Warming Relief Cold and Chest Congestion, 8.3 oz.
  • Theraflu® Warming Relief Sinus and Cold, 8.3 oz.
  • Triaminic® Chest and Nasal Congestion, 4 oz
  • Triaminic® Cold and Allergy, 4 oz
  • Triaminic® Cough and Sore Throat, 4 oz.
  • Triaminic® Day Time Cold and Cough, 4 oz
  • Triaminic® Daytime/Nighttime Cold & Cough Club Pack
  • Triaminic® Daytime/Nighttime Cold & Cough Combo Pack
  • Triaminic® Dye-free Long Acting Cough, 4 oz.
  • Triaminic® Fever Reducer Pain Reliever Bubblegum, 4 oz
  • Triaminic® Fever Reducer Pain Reliever Grape, 4 oz.
  • Triaminic® Fever Reducer Pain Reliever Infant Bubblegum, 2 oz.
  • Triaminic® Fever Reducer Pain Reliever Infant Grape, 2 oz.
  • Triaminic® Multi Symptom Fever, 3.4 oz.
  • Triaminic® Multi Symptom Fever, 4 oz.
  • Triaminic® Night Time Cold and Cough, 3.4 oz.
  • Triaminic® Night Time Cold and Cough, 4 oz.

A full listing of the lots recalled is provided here: http://www.novartis-otc.com/triaminic_theraflu_recall_2013.pdf

Next Steps

The manufacturer encourages all consumers with a recalled product to return the product to the manufacturer for a full refund. The Novartis website has forms posted to fill out to obtain full refunds for the products. Further contact information is available below:

Novartis Consumer Relationship Center:
1-866-553-6742
Mon-Sat., 8a.m. – 12a.m. ET
http://www.novartis-otc.com/recall_theraflu_triaminic.html

If your child has been harmed by a defective or recalled product, contact us for a free case evaluation today!

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