September 2013 FDA Recall Drug by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
D-66272-001 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. on September 6, 2013 for the product Drug. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-66272-001

Reason for Recall
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Initiated
09-06-2013
Reported
10-23-2013
Quantity
197,532 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66272
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15