June 2017 FDA Recall Drug by L. Perrigo Company
D-0925-2017 - Labeling

This Class III drug recall was voluntarily initiated by L. Perrigo Company on June 5, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in IL and the recall is currently terminated.

Recall Number: D-0925-2017

Reason for Recall
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Initiated
06-05-2017
Reported
07-05-2017
Quantity
1,998 combo packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77450
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 Company
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.
IL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2017
Product Description About Product Description
Full technical description of the product.
Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015

Batch or Lot Expiration Information

Lot# : 6MV0944, Exp 10/18