D-1517-2016 Class III Terminated
FDA drug recall D-1517-2016 was initiated by Reckitt Benckiser LLC on August 3, 2016 and is designated Class III. 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 inste… The recall status is terminated (terminated March 5, 2018). Affected quantity: 738 boxes.
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