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U.S. Department of Health and Human Services

Enforcement Report - Week of October 23, 2013

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Event Detail

Event ID 66272
Product Type Drugs
Status Ongoing
Recalling Firm Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
City Fort Washington
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA. Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15 Class II Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed 197,532 bottles D-66272-001