Amgen has issued a voluntary recall for nearly 1 million bottles of the heart medication Corlanor (ivabradine) due to possible contamination.
The nationwide recall was issued by the company June 4 and was classified by the FDA as a Class II recall on June 23. Amgen took the action after the presence of a possible foreign substance was discovered, according to FDA records.
Two separate notices concerning the action were issued by the regulatory agency, with one citing 934,577 5-mg bottles of Corlanor in 14-tablet and 60-tablet containers.
The company also issued a recall for an undisclosed number of 7.5 mg 60-count bottles. All the recalled heart pills were produced in Italy.
The drug is typically used to treat chronic heart failure in adults and for children 6 months or older experiencing stable heart failure symptoms caused by an enlarged heart.
The company also initiated a nationwide recall for 9,565 bottles of 30-mg, 30-count bottles of Sensipar (cinacalcet) that is used to treat hyperparathyroidism in dialysis patients and high blood calcium that can be triggered by parathyroid cancer or severe primary hyperparathyroidism.
The California drugmaker further issued recalls due to manufacturing deviations for an undisclosed number of 90-mg, 30-count bottles and 60-mg, 30-count bottles of Sensipar that the FDA has called a Class II action. The recalled Sensipar tablets were all manufactured in Japan, and the dates for those recalls posted on the agency’s website are the same as for Corlanor.
The recalls fell at the same time Amgen got bad news that European Union regulators recommended its ANCA-associated vasculitis drug Tavneos lose its authorization in the wake of a review that found the drug’s benefits were “no longer proven to outweigh its risks.”
A final decision by the European Commission was expected to be handed down soon. Amgen is also bracing for an FDA hearing to address efficacy and safety concerns regarding Tavneos.