Drug Enforcement D-1056-2013

Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.

Status

Terminated

Classification

Class II

Report Date

September 25, 2013

Termination Date

September 18, 2014

Product Information

Product description
Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12
Product quantity
11,337 twin packs
Reason for recall
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
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-1056-2013
Event ID
66157
Recall initiation date
August 29, 2013
Center classification date
September 13, 2013
Code info
Lot #s 31614334R1, 31814334R1, Exp 5/15; Twin packs were further packaged in display coded with following 4 Lot #s (display received by WalMart only): 3051A152HK, Exp 1/15, 3051A152HL, Exp. 1/15, 3051A152HM, Exp 1/15, 30746493F5, Exp 2/15
More code info