Recalls / Class III
Class IIID-1517-2016
Product
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
- Affected lot / code info
- WO00809739, 9/2017
Why it was recalled
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.
Recalling firm
- Firm
- Reckitt Benckiser LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 399 Interpace Pkwy, Parsippany, New Jersey 07054-1133
Distribution
- Quantity
- 738 boxes
- Distribution pattern
- FL, MA and NJ
Timeline
- Recall initiated
- 2016-08-03
- FDA classified
- 2016-09-22
- Posted by FDA
- 2016-09-28
- Terminated
- 2018-03-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1517-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.