Amgen has initiated a massive voluntary recall involving over 944,000 bottles of heart and kidney medications distributed throughout the United States. Triggered by the discovery of a foreign substance on the surface of certain tablets and identified manufacturing inconsistencies, the recall serves as a proactive measure to ensure consumer safety despite no reported illnesses or injuries.
Key takeaways
- More than 944,000 units of medication have been recalled nationwide.
- Affected medications include Corlanor, used for heart failure, and Sensipar, used for kidney health.
- The FDA has categorized this as a Class II recall, signaling a low probability of serious adverse health effects.
- No consumer complaints or medical incidents have been linked to this recall.
Understanding the recall
The U.S. Food and Drug Administration (FDA) announced the recall after discovering that a foreign substance was present on the exterior coating of tablets in select batches. This issue was pinpointed to a specific packaging area within an Amgen facility. Furthermore, some lots were found to have deviated from Current Good Manufacturing Practice (CGMP) standards, which could potentially influence the safety and efficacy of the medication.
Affected medications
The recall encompasses several presentations of Corlanor (ivabradine) and Sensipar (cinacalcet). Affected inventory includes different tablet strengths processed in specific packaging environments. Patients are encouraged to cross-reference their medication bottles with the specific lot codes and expiration dates provided in the official FDA recall notice.
| Medication | Strength |
|---|---|
| Corlanor (ivabradine) | 5 mg |
| Corlanor (ivabradine) | 7.5 mg |
| Sensipar (cinacalcet) | 30 mg |
| Sensipar (cinacalcet) | 60 mg |
| Sensipar (cinacalcet) | 90 mg |
Safety assessment and next steps
While the FDA has labeled this a Class II recall—meaning there is a remote risk of serious consequences and the potential for temporary, reversible health issues—the overall patient safety risk is currently assessed as low. Amgen has confirmed that external assessments currently suggest no immediate threat to users.
Patients who find that their medication is included in the recall should not abruptly stop their treatment, as this could be counterproductive for their heart or kidney conditions. Instead, consult your prescribing physician or pharmacist immediately to verify the safety of your supply and arrange for a refund or a replacement bottle.
Sources
- FDA Recalls Heart and Kidney Medications Nationwide, EatingWell.
- Heart, kidney prescription medications recalled – NBC Chicago, NBC 5 Chicago.
- Nearly 1 million bottles of heart and kidney medication recalled: FDA, Fox Business.
- Two widely used kidney and heart medications recalled due to ‘foreign substance’, NewsNation.