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Class III: unlikely to cause harmTerminated

Reckitt Benckiser Mucinex Sinus-Max Day Night Recall

Mucinex Sinus-Max Day Night, 60 caplets, Dist

Reckitt Benckiser LLC · Parsippany, NJ

Risk level
Class III
Reported by FDA
Sep 28, 2016
Recall ID
D-1517-2016
Check your lot numberHow we source this data

Summary

Reckitt Benckiser recalled Mucinex Sinus-Max Day Night starting Aug 3, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1517-2016 on Sep 28, 2016. Reason: 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. Status: Terminated.

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.

Product description

Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

Lot numbers, UPCs & expiration codes

WO00809739, 9/2017

Where it was sold

FL, MA and NJ

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1517-2016
Classification
Class III
Status
Terminated
Recall initiated
Aug 3, 2016
FDA report date
Sep 28, 2016
Quantity
738 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
Reckitt Benckiser LLC

Original FDA data

Every field from FDA enforcement report D-1517-2016, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
74965
Address
399 Interpace Pkwy
Code information
WO00809739, 9/2017
Postal code
07054-1133
Report date
Sep 28, 2016
Product type
Drugs
Recall number
D-1517-2016
Classification
Class III
Recalling firm
Reckitt Benckiser LLC
Product quantity
738 boxes
Termination date
Mar 5, 2018
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Distribution pattern
FL, MA and NJ
Recall initiation date
Aug 3, 2016
Initial firm notification
Letter
Center classification date
Sep 22, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1517-2016, published Sep 28, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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