Pharmacy Drug Recall Action Verification

Inspection template to verify pharmacy response to an FDA drug recall, including inventory removal, patient notification, documentation, and replacement actions.

Inspection Details

• Recall notice identified and documented
• Recall classification and affected lot numbers recorded
• Inspection date and time
• Inspector name and role
• Pharmacy location / department inspected

Inventory Removal and Quarantine

• All recalled product removed from active dispensing stock
• Recalled product quarantined in a clearly labeled, segregated area
• Quarantine area prevents accidental dispensing or access
• Inventory count of affected units matches recall scope
• Expired, opened, or damaged recalled stock handled per SOP

Patient and Prescriber Notification

• Affected patients identified using dispensing records
• Prescribers notified for affected patients when required
• Patient notification method documented
• Notification records include date, time, contact outcome, and follow-up needed
• Patients instructed on replacement, return, or disposal steps

Documentation and Disposition

• Recall log completed with product, lot, quantity, and disposition
• Returned, destroyed, or vendor-credited units documented
• Supporting evidence retained per policy
• Root cause or recall reason documented
• Responsible pharmacist or manager reviewed and signed off

Replacement and Corrective Actions

• Replacement stock ordered or alternative therapy arranged
• Affected patients' therapy continuity addressed without delay
• Corrective action plan created for any gaps identified
• Follow-up verification date scheduled