Drug Enforcement D-827-2013

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.

Status

Terminated

Classification

Class II

Report Date

August 7, 2013

Termination Date

October 8, 2014

Product Information

Product description
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.
Product quantity
35,568 cartons
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.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Procter & Gamble Co
Address
8700 Mason Montgomery Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-827-2013
Event ID
65650
Recall initiation date
July 3, 2013
Center classification date
July 26, 2013
Code info
Lot # 3051171961, Exp 09/14; Brand Code 84855363
More code info