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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
E-Mail
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
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