February 2013 FDA Recall Drug by L. Perrigo Co.
D-216-2013 - Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.

This Class III drug recall was voluntarily initiated by L. Perrigo Co. on February 18, 2013 for the product Drug. The FDA reported the reason for recall as subpotent; 12 month time point for the active ingredient phenylephrine hcl.. The product was distributed in Walmart Distribution Center in Bentonville, AR and the recall is currently terminated.

Recall Number: D-216-2013

Reason for Recall
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Initiated
02-18-2013
Reported
04-03-2013
Quantity
60,048 Blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64388
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.
L. Perrigo Co.
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.
Walmart Distribution Center in Bentonville, AR
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-12-2013
Product Description About Product Description
Full technical description of the product.
PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716

Batch or Lot Expiration Information

Lot# 2 AE1549 Exp. 02/13