July 2013 FDA Recall Drug by Procter & Gamble Co
D-827-2013 - Unit Dose Mispackaging

This Class II drug recall was voluntarily initiated by Procter & Gamble Co on July 3, 2013 for the product Drug. The FDA reported the reason for recall as unit dose mispackaging. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-827-2013

Reason for Recall
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
Initiated
07-03-2013
Reported
08-07-2013
Quantity
35,568 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65650
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-08-2014
Product Description About Product Description
Full technical description of the product.
DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1.

Batch or Lot Expiration Information

Lot# 3051171961, Exp 09/14; Brand Code 84855363