August 2016 FDA Recall Drug by Reckitt Benckiser Llc
D-1517-2016 - Labeling

This Class III drug recall was voluntarily initiated by Reckitt Benckiser Llc on August 3, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in FL, MA and NJ and the recall is currently terminated.

Recall Number: D-1517-2016

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.
Initiated
08-03-2016
Reported
09-28-2016
Quantity
738 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74965
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Reckitt Benckiser LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MA and NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-05-2018
Product Description About Product Description
Full technical description of the product.
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

Batch or Lot Expiration Information

Lot# WO00809739, 9/2017