FDA-Drug2013-01-30Class III
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
Axcentria Pharmaceuticals LLC
Hazard
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.
Sold states
MI
Affected count
17,679 bottles
Manufactured in
306 Keystone Dr, Unit B, Telford, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-134-2013Don't want to check this manually?
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