Drug recall D-1517-2016

Class III Terminated reported Sep 28, 2016

Product

Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

Reason for recall

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.

Lots and codes

WO00809739, 9/2017

Recall details

Recalling firm
Reckitt Benckiser LLC, Parsippany, NJ
Quantity
738 boxes
Distribution
FL, MA and NJ
Type
Voluntary: Firm initiated
Recall initiated
August 3, 2016
Terminated
March 5, 2018