November 2012 FDA Recall Drug by Procter & Gamble Co
D-069-2013 - Labeling Illegible

This Class II drug recall was voluntarily initiated by Procter & Gamble Co on November 8, 2012 for the product Drug. The FDA reported the reason for recall as labeling illegible. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-069-2013

Reason for Recall
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Initiated
11-08-2012
Reported
12-05-2012
Quantity
17,532 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63661
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.
Procter & Gamble 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-23-2013
Product Description About Product Description
Full technical description of the product.
Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12

Batch or Lot Expiration Information

Lot# 2278171941, Exp. 09/14
Lot# 2282171981, Exp. 09/14 .