Nearly 1 million bottles of heart and kidney medication recalled over foreign substance found on tablets - Fox Business

Nearly one million bottles of heart and kidney medication have been recalled nationwide over the possibility of a "foreign substance," according to the U.S. Food and Drug Administration. California-based Amgen, Inc. voluntarily recalled at least 944,142 bottles of Corlanor and Sensipar tablets after "unexpected foreign matter" was found "in the reserve sample of one of the identified lots," the California state Board of Pharmacy said in an alert. "The unexpected foreign matter was localized on the exterior tablet surface, over the coating," the board said. "Therefore, as a precautionary measure, all lots within expiry that were processed in AML Building 23 packaging area, where the condition occurred, are being recalled." The board added that hazard assessments have found it doesn’t present a clinical risk to patients and "overall patient safety risk is low." COSTCO-BRAND COLD AND FLU MEDICATION RECALLED BY FDA: 'NOT EFFECTIVE' There have been no complaints about the issue. Corlanor, which is also known by the generic name ivabradine, is prescribed to treat patients with chronic heart failure and Sensipar, also known as cinacalcet hydrochloride, is mainly used to treat overactive parathyroidism in chronic kidney disease patients. The tablets were distributed between Oct. 28, 2021 and Dec. 30, 2025. 19 DRUG APPROVALS IN 2024 THAT HAD 'BIG CLINICAL IMPACT,' ACCORDING TO GOODRX The recall includes the following presentations, according to the board: • Corlanor® (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-800-60 • Corlanor® (ivabradine) 5 mg, 14 tablets in 1 bottle; NDC 55513-800-99 • Corlanor® (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-810-60 • Sensipar® (cinacalcet hydrochloride) 30 mg, 30 tablets in 1 bottle; NDC 55513-073- 30 • Sensipar® (cinacalcet hydrochloride) 60 mg, 30 tablets in 1 bottle; NDC 55513-074- 30 • Sensipar® (cinacalcet hydrochloride) 90 mg, 30 tablets in 1 bottle; NDC 55513-075- 30