Novartis Recalls More Than 5 Million Physicians’ Samples
Novartis AG (NYSE:NVS) recalled more than five million blood pressure medications, including Exforge and Exforge HCT, Tekturna, Tekturna HCT, and Diovan, along with others, including Stalevo, a medication that treats Parkinson’s disease and Lescol XL, a drug that helps lower cholesterol. The majority of the recall was for Novartis’ blood pressure medications Exforge and Exforge HCT, which encompassed 4.7 million bottles. That recall began over the summer, but now has expanded to include several other sample drugs produced by the company.
The drugs were contaminated by a photocuring agent used in ink and shrink wrapped sleeves during the packaging process, according to an FDA enforcement report, published December 18. Of the sample drugs, 127 lots contained a trace amount of the ink component, which have leeched and affected some of the tablets in the seven-tablets-each physician sample bottles.
The company has concluded that the contamination with the ink component doesn’t pose a safety risk for patients, but that the recall was initiated voluntarily “to ensure compliance with regulatory standards and quality control,” a Novartis spokesperson said. The FDA has classified that samples recall a “Class 2″ recall, which is reserved for instances in which the chance of any serious adverse health condition is remote.