FDAFDA · Food and drugs·Recall number D-1517-2016
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Published September 28, 2016 · Recall initiated: August 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Reckitt Benckiser LLC
- Distributor
- FL, MA and NJ
- Lot
- WO00809739, 9/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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