Novartis Consumer Health has announced that it is voluntarily recalling certain lots of Triaminic Syrups and Theraflu Warming Relief Syrups that were manufactured in the United States before December 2011. Novartis Consumer Health has decided to issue 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.
Novartis Consumer Health received four adverse events related to this issue on bottles of Triaminic Syrups. There were no reports of adverse events related to this specific issue for Theraflu Warming Relief Syrups.
Triaminic Syrups and Theraflu Warming Relief Syrups continue to be safe and effective when used as directed on the package label.
The products being recalled were produced at the Novartis Consumer Health manufacturing facility in Lincoln, Nebraska prior to the voluntary suspension of operations and shipments at the facility in December 2011. A consumer complaint in the US in late November 2012 triggered an internal investigation by Novartis Consumer Health that determined a voluntary recall was in the best interest of consumers.
The affected bottle sizes are attached to this release. The lot number is 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 box and the upper left corner of the Theraflu bottle.
Novartis Consumer Health advises consumers who think they might have the product(s) being recalled to visit our website at www.novartisOTC.com or contact the Novartis Consumer Relationship Center at 866-553-6742 (available Monday-Saturday 8 a.m. to midnight Eastern Time) for more detailed information about the recall, including which lot numbers are impacted, and for information on how to return the affected products and receive a full refund. Retailers and wholesalers should stop distribution and return the affected lots using the Novartis Product Return information that is being provided to them.
Adverse events that may be related to the failure of child-resistant packaging of these products may be reported to the Novartis Consumer Relationship Center at 866-553-6742 (available Monday-Saturday 8 a.m. - midnight Eastern Time) or the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).
Source: Novartis via PR Newswire