Drug product
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.
D-827-2013
Product summary
- Event
- Event 65650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,568 cartons
- Official record key
drug-enforcement:D-827-2013
Official wording
Reason: 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.
Code information: Lot # 3051171961, Exp 09/14; Brand Code 84855363
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Mispackaging