Drug product
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
D-1517-2016
Product summary
- Event
- Event 74965
- Status
- Terminated
- Classification
- Class III
- Quantity
- 738 boxes
- Official record key
drug-enforcement:D-1517-2016
Official wording
Reason: Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Code information: WO00809739, 9/2017
Distribution pattern: FL, MA and NJ
Derived failure modes
-
Labeling or packaging
Labeling: Label Error