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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62628
Product Type Drugs
Status Ongoing
Recalling Firm Axcentria Pharmaceuticals LLC
City Telford
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern Michigan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30, Lot D12044, Exp 4/2014, NDC 0904-5255-30 Class III Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014 13,128 bottles D-1441-2012