Status
Terminated
Drug Enforcement D-134-2013
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.
Classification
Class III
Report Date
January 30, 2013
Termination Date
October 7, 2014
Product Information
- 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
- Product quantity
- 17,679 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- MI
Location & Firm
- Recalling firm
- Axcentria Pharmaceuticals LLC
- Address
-
306 Keystone Dr, Unit B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-134-2013
- Event ID
- 62983
- Recall initiation date
- August 17, 2012
- Center classification date
- January 18, 2013
- Code info
- Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.
- More code info
- —