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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Event Detail

Event ID 62983
Product Type Drugs
Status Ongoing
Recalling Firm Axcentria Pharmaceuticals LLC
City Telford
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern MI

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014. Class III 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. 17,679 bottles D-134-2013
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