Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1056-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 29, 2013
- FDA report date
- Sep 25, 2013
- Quantity
- 11,337 twin packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Procter & Gamble Co
Original FDA data
Every field from FDA enforcement report D-1056-2013, exactly as published.
Show all FDA fields
- City
- Mason
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 66157
- Address
- 8700 Mason Montgomery Rd
- 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
- Postal code
- 45040-9462
- Report date
- Sep 25, 2013
- Product type
- Drugs
- Recall number
- D-1056-2013
- Classification
- Class II
- Recalling firm
- Procter & Gamble Co
- Product quantity
- 11,337 twin packs
- Termination date
- Sep 18, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 29, 2013
- Initial firm notification
- Letter
- Center classification date
- Sep 13, 2013