Novartis Consumer Health recalls OTC syrups

Novartis Consumer Health is voluntarily recalling certain Triaminic Syrups and Theraflu Warming Relief Syrups that were manufactured in the United States before Dec. 31, 2011.

To see the full list of recalled products, click here.

The company is issuing the recall to U.S. consumers, retail customers, and wholesalers because the child-resistant feature of the bottle cap may not function correctly, enabling the cap to be removed with the tamper-evident seal still in place.

Novartis received four adverse event reports related to this issue on the Triaminic syrup bottles. No adverse events were reported with the Theraflu syrup. Both products continue to be safe and effective when used as directed.

The products were produced at the Novartis Consumer Health manufacturing facility in Lincoln, Neb., prior to the voluntary suspension of operations and shipments at the facility in December 2011.

For more information on the recall and how to return the affected products for a refund, consumers can:

• Visit the Novartis website

• Call the company’s Consumer Relationship Center at 866-553-6742, Monday through Saturday from 8 a.m. to midnight EST

• Email the relationship center at Novartisotc.nchus@novartis.com

Retailers and wholesalers should stop distribution and return the affected lots to receive a full refund using the product return information that will be provided to them.

Any adverse events concerning these products should be reported to FDA’s MedWatch Adverse Reporting Program:

• Online: www.fda.gov/medwatch/report.htm

• Regular mail: postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm

• Fax: 1-800-FDA-0178