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Recall Observatory FDA recall evidence

Drug product

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

D-1056-2013

August 29, 2013

Class II

Product summary

Firm
Procter & Gamble Co
Event
Event 66157
Status
Terminated
Classification
Class II
Quantity
11,337 twin packs
Official record key
drug-enforcement:D-1056-2013

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.