Drug Enforcement D-66272-001

Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed

Status

Terminated

Classification

Class II

Report Date

October 23, 2013

Termination Date

December 2, 2014

Product Information

Product description
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.
Product quantity
197,532 bottles
Reason for recall
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Address
7050 Camp Hill Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-66272-001
Event ID
66272
Recall initiation date
September 6, 2013
Center classification date
October 17, 2013
Code info
Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15
More code info