Novartis Consumer Health, Inc. voluntarily recalling in the US select lots of certain over-the-counter products due to bottle closure defect
PARSIPPANY, N.J., Jan. 31, 2013 /PRNewswire/ — Novartis Consumer Health, Inc. announced today 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.
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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).
The foregoing release contains forward-looking statements including express or implied discussions regarding potential future revenues from Novartis OTC products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Novartis OTC products will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding such products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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