FDAFDA · Food and drugs·Recall number D-134-2013
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
Published January 30, 2013 · Recall initiated: August 17, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Axcentria Pharmaceuticals LLC
- Distributor
- MI
- Lot
- Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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