Endo USA has expanded its recall of Clonazepam Orally Disintegrating Tablets USP due to carton strength mislabeling, posing risks of incorrect dosing. While blister packs inside cartons are correctly labeled, patients taking higher doses inadvertently face serious risks such as sedation, dizziness, or life-threatening respiratory depression. The affected lots were distributed nationwide.

Impact on Home Health Agencies 

• Patient Safety Risks: Home health patients, particularly those with neurological conditions or respiratory vulnerabilities, may face heightened risks from incorrect dosing.
• Caregiver Challenges: Mislabeling may cause confusion for caregivers administering medication.
• Operational Strain: Agencies may need to address patient concerns, coordinate medication replacements, and manage increased monitoring for adverse effects.

Recommended Actions for Home Health Agencies

Educate Staff: Train caregivers to verify medication strength using blister packs, not cartons, and monitor for adverse effects.

• Communicate with Patients: Inform patients and families about the recall and assist them in checking and replacing affected products.
• Facilitate Replacements: Help patients contact pharmacies or Inmar (855-589-1869 or rxrecalls@inmar.com) for returns and replacements.
• Report Adverse Events: Encourage reporting of any side effects to the FDA’s MedWatch program.

By staying proactive, home health agencies can safeguard patient safety, ensure continuity of care, and maintain trust throughout this recall.