drugs Class III Updated 2013-01-30

Axcentria Pharmaceuticals LLC recalls Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: MI
Lot/Code Info: Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.
View official government recall

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