Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03

Recall Number: D-134-2013

Firm: Axcentria Pharmaceuticals LLC

Classification: Class III

Status: Terminated

Report Date: 20130130

Initiation Date: 20120817

Termination Date: 20141007

Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.

Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03