Novartis Issues Recall Because of Broken, Mixed Medicines

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Novartis said on Sunday that it is voluntarily recalling certain lots of over-the-counter products because they might contain broken or stray tablets from other products [1]. The recall comes following consumer complaints of chipped and broken pills, and inconsistent bottle packaging line clearance practices (meaning cleaning and clearance operations that are performed when a product or strength change occurs during medicine packaging) that may have possibly resulted in mixed tablets.

The recall affects select bottle packaging configurations from retailers of Excedrin and NoDoz products with expiration dates of December 20, 2014 or earlier and Bufferin and Gas-X Prevention products with expiration dates of December 20, 2013 or earlier, in the United States.

The issue arises from manufacturing problems at the company’s Lincoln, Nebraska facility. Novartis voluntarily halted production at the plant on December 19th, 2011. The FDA has cited the Novartis plant for quality control problems over the summer 2011 [2]. Among the 13 FDA inspector observations, Novartis officials have failed to adequately investigate 166 complaints of foreign tablets in bottles since 2009. On Monday, January 9th, FDA officials warned that some of Novartis’ over-the-counter medications may have accidentally been packaged with opiate products manufactured and packaged for Endo Pharmaceuticals, which are made at the same facility [3].

No related adverse events have been reported as a result of these issues. U.S. Consumers are being asked to either destroy or return unused product identified in the recall to Novartis Consumer Health Inc. Information on the affected bottle sizes, and related expiration dates are available at www.novartisOTC.com.

The Novartis recalls come just over six months after Johnson & Johnson recalled over 40 products due to what was believed to have been contaminating breakdown products from a fungicide used to treat wooden pallets on which empty product containers were stored.

References

1. Novartis Consumer Health Inc. voluntarily recalls certain over-the- counter products in the US while Novartis Group strengthens quality standards across all manufacturing sites. Novartis media release. 2012 Jan 8.
2. Novartis Consumer Health, Lincoln, NE 483 issued 7/8/2011. U.S. Food and Drug Administration. Accessed 2012 Jan 9.
3. Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory – Potential Safety Risk. U.S. Food and Drug Administration. 2012 Jan 9.