FDA recall D-134-2013

Axcentria Pharmaceuticals LLC · Class III · drug

Product

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

Reason for recall

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.

Distribution

Key facts

Status: Terminated
Initiation date: 2012-08-17
Report date: 2013-01-30
Termination date: 2014-10-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-134-2013