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
Product summary
- 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
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.