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Axcentria Pharmaceuticals LLC recalls Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Dr

Recalled January 30, 2013 · FDA recall D-134-2013 · Axcentria Pharmaceuticals

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. · FDA Class III
Units
17,679 bottles
Sold at
MI

Description

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.

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
Manufacturer(s)
Axcentria Pharmaceuticals LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Axcentria Pharmaceuticals LLC recalls Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Dr | RecallWatchUSA