Expert Recall

Millions of patients were alarmed to learn that their medicine had been linked to an increased risk of heart attack. Within days the pharmaceutical company notified the Food and Drug Administration that it was voluntarily withdrawing the medicine from the market. This resulted in the largest pharmaceutical withdrawal in U.S. history.

The ExpertRECALL™ team managed the recall.

• ExpertRECALL quickly coordinated over a half million overnight traceable document deliveries to notify physician offices, pharmacies and hospitals.

• An inbound interactive voice response (IVR) system handled hundreds of thousands of patient and physician phone calls, providing up-to-the minute information and capturing requests for reimbursements and return kits for affected product.

• Tens of thousands of reimbursement checks were printed and mailed within days and all returned products were processed at an ExpertRECALL storage facility and tracked for full reporting and compliance with the FDA.

This recall experience was one of many that led to FDA’s adoption of ExpertRECALL’s notification document package format which is widely used and recognizable throughout the industry today.

Protecting People – Reducing Risk