Class III
Terminated
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
- Company
- Axcentria Pharmaceuticals Llc
- Recall Initiated
- August 17, 2012
- Posted
- January 30, 2013
- Recall Number
- D-134-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17,679 bottles
- Firm Location
- Telford, PA, United States
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
MI
Lot / Code Info
Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.
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