D-1517-2016 Class III Terminated

Recalled by Reckitt Benckiser LLC — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
September 28, 2016
Initiation Date
August 3, 2016
Termination Date
March 5, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
738 boxes

Product Description

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.

Distribution Pattern

FL, MA and NJ

Code Information

WO00809739, 9/2017