Novartis Consumer Health, Inc. (NCH) is voluntarily recalling certain lots of Triaminic® Syrups and Theraflu Warming Relief® Syrups that were manufactured in the United States before December 31, 2011. Novartis Consumer Health has decided to issue a voluntary recall to consumers, retail customers and wholesalers in the U.S. because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place.
Please click here to see the full listing of recalled products including Lot and NDC numbers to determine if you are in possession of one of these recalled products. The lot number is located on the bottom panel of the box and on the left side of the label on the bottle, please click here to view examples. The NDC number is located on the upper right corner of the front panel of the box for Triaminic®, and the upper left corner of the front of the bottle for Theraflu®. Please click here to view examples.
We are instructing consumers, our retail partners, and wholesalers to return the products for a full refund. See below for information on how to return impacted products.
To view the recall FAQ, please click here.
Consumers with additional questions are encouraged to contact the Novartis Consumer Relationship Center at 1-866-553-6742 (available Monday – Friday 8 a.m. – 10 p.m. EST).
To return a recalled product and obtain a refund, please follow these steps:
Consumers can contact the Novartis Consumer Relationship Center via email at Novartisotc.nchus@novartis.com or call 866-553-6742, Monday – Friday 8 a.m. – 10 p.m. EST, for information on the voluntary recall and how to return the affected products and receive reimbursement.
Novartis Consumer Health initiated a voluntary recall to consumers, retail customers and wholesalers in the US because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place.
Click here for impacted lot and NDC numbers.
The lot number is located on the bottom panel of the box and on the left side of the label on the bottle, please click here to view examples. The NDC number is located on the upper right corner of the front panel of the box for Triaminic®, and the upper left corner of the front of the bottle for Theraflu®, please click here to view examples.
If you determine you have an affected product, download the appropriate refund form by clicking the attached link: Theraflu® Refund Form and Triaminic® Refund Form. Mail any remaining product in the original container along with a completed refund form to the following address. Please allow 8-12 weeks for processing.
Novartis Consumer Health, Inc.
600 Lasley Ave.
Wilkes Barre, PA 18706
We are asking retailers and wholesalers to stop distribution and return the affected lots using the Novartis Product Return information that is being provided to them.
Consumers may contact the Novartis Consumer Relationship Center at 1-866-553-6742 (available Monday – Friday 8 a.m. – 10 p.m. EST).
Consumers, retail customers and wholesalers in the United States are impacted.
Yes, Triaminic® Syrups and Theraflu Warming Relief® Syrups continue to be safe and effective when used as directed on the package label. However, for the identified lots, it is possible the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place, so as a precaution, we are instructing consumers to return the product for a full refund.
Triaminic® Syrups and Theraflu Warming Relief® Syrups continue to be safe and effective when used as directed on the package label. However, for the identified lots, it is possible the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place. As a precaution we are instructing consumers to return the product for a full refund.
If you have any questions or are experiencing an adverse event, you should contact your physician or healthcare provider as soon as possible. Adverse events that may be related to the failure of child-resistant packaging of these products may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax
We are advising consumers who think they may have product(s) that are being recalled to return them to Novartis Consumer Health for a full refund.
If you determine you have an affected product, download the appropriate refund form by clicking the attached link: Theraflu Refund Form Theraflu® Refund Form and Triaminic® Refund Form. Mail any remaining product in the original container along with a completed refund form to the following address.
Novartis Consumer Health, Inc.
600 Lasley Ave.
Wilkes Barre, PA 18706
Please allow 8-12 weeks for processing.
The Triaminic® products that were re-introduced in October 2012 are not part of the voluntary recall. If the lot number, which contains 7 digits, has two letters as its second and third digits, it is not part of the voluntary recall, as the tamper-evident seal does not affect the child resistant cap.
The lot number is located on the bottom panel of the box and on the left side of the label on the bottle, please click here to view examples. The NDC number is located on the upper right corner of the front panel of the box for Triaminic®, please click here to view examples.