May 2012 FDA Recall Drug by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
D-1404-2012 - Defective Container; damaged blister units

This Class III drug recall was voluntarily initiated by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. on May 17, 2012 for the product Drug. The FDA reported the reason for recall as defective container; damaged blister units. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1404-2012

Reason for Recall
Defective Container; damaged blister units
Initiated
05-17-2012
Reported
07-11-2012
Quantity
53,892 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61872
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
04-11-2013
Product Description About Product Description
Full technical description of the product.
Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA

Batch or Lot Expiration Information

Lot# CMF023, Expiration 07/13.