Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Lot # 3051171961, Exp 09/14; Brand Code 84855363
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-827-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 3, 2013
- FDA report date
- Aug 7, 2013
- Quantity
- 35,568 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Procter & Gamble Co
Original FDA data
Every field from FDA enforcement report D-827-2013, exactly as published.
Show all FDA fields
- City
- Mason
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 65650
- Address
- 8700 Mason Montgomery Rd
- Code information
- Lot # 3051171961, Exp 09/14; Brand Code 84855363
- Postal code
- 45040-9462
- Report date
- Aug 7, 2013
- Product type
- Drugs
- Recall number
- D-827-2013
- Classification
- Class II
- Recalling firm
- Procter & Gamble Co
- Product quantity
- 35,568 cartons
- Termination date
- Oct 8, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 3, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 26, 2013