D-134-2013 Class III Terminated
FDA drug recall D-134-2013 was initiated by Axcentria Pharmaceuticals LLC on August 17, 2012 and is designated Class III. 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. The recall status is terminated (terminated October 7, 2014). Affected quantity: 17,679 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 30, 2013
- Initiation Date
- August 17, 2012
- Termination Date
- October 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,679 bottles
Product Description
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
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 Pattern
MI
Code Information
Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.