More than 5 million blood pressure pills distributed as samples to doctors have been recalled by Novartis AG after it was found that traces of a photocuring agent used in ink and shrink wrapped sleeves during the packaging process somehow leaked into 127 lots.
The medications including Exforge and Exforge HCT, Tekturna, Tekturna HCT, and Diovan. An additional recall was also issued for samples of Lescol XL, used to lower cholesterol and Stalevo a drug for treating Parkinson’s disease
Although Novartis stated that they contamination poses no threat to patients, they have voluntarily decided to recall the pills as a precaution and “to ensure compliance with regulatory standards and quality control,” according to a company spokesperson.
The FDA has classified that samples recall a “Class 2″ recall, which is used in cases where it considers “the chance of any serious adverse health condition is remote.”
Readers with questions should speak to their doctors, or contact the FDA at 888 Info-FDA.