Anna Hartz
FDA recalls medications after foreign substance found in some bottles
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Important note: People who have one of the affected bottles should not stop taking their medication without first speaking to a healthcare provider. Instead, they should contact the doctor who prescribed the medicine or the pharmacy where it was filled. They can ask about getting a replacement or a refund.
Fails to meet quality standards
Medication recalls happen from time to time to protect patients from possible safety problems. While many recalls do not involve serious health risks, people who take prescription medicines should always check whether their medication has been affected.
More than 944,000 bottles of prescription heart and kidney medicines have been recalled across the United States, according to the U.S. Food and Drug Administration, reports EatingWell.
The recall affects products distributed by Amgen. The FDA said the action was taken because of the presence of a foreign substance in some bottles. The agency also cited manufacturing problems that did not meet current quality standards.
The recalled medicines include several strengths and package sizes of Corlanor, also known as ivabradine, and Sensipar, also known as cinacalcet.
Corlanor is commonly prescribed to some patients with chronic heart failure. Sensipar is used to treat certain people with chronic kidney disease and hyperparathyroidism.
The recall includes Corlanor 5 milligram tablets in both 14-count and 60-count bottles. It also includes Corlanor 7.5 milligram tablets in 60-count bottles.
Class II recall
Several strengths of Sensipar are also included. These are the 30 milligram, 60 milligram and 90 milligram tablets in 30-count bottles.
Only certain lot numbers and expiration dates are affected. Patients should check the information printed on their prescription bottle to see if it matches the recall notice.
The FDA has classified the recall as a Class II recall. This means the affected medicines could cause temporary or medically reversible health problems. The agency says the risk of serious health effects is considered low.
So far, no illnesses or injuries have been reported in connection with the recalled products.
The recall does not affect any other medications.
Anyone who has questions about the recall can contact the U.S. Food and Drug Administration through its information line. Patients who feel unwell or believe they may have been affected by a recalled product should seek medical advice as soon as possible.
