Drug recall: Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC…
Class III FDA enforcement event 74965. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Reckitt Benckiser LLC started this drug recall on 3 Aug 2016. The firm address in the FDA record is in Parsippany, NJ. FDA put the recall in Class III. FDA event 74965 has 1 product record. The first FDA enforcement report date is 28 Sep 2016. The record gives the status Terminated, with the termination date 5 Mar 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
FL, MA and NJ
Recalling firm
Reckitt Benckiser LLC, Parsippany, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1517-2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 | 738 boxes | Class III | Terminated | 28 Sep 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2016
- 288
- Share of these events in Class III
- 43%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Dec 2018 | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 0234 | Device | Class II | 2 |
| 6 Aug 2018 | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prop | Device | Class II | 1 |
| 23 Jul 2018 | Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage | Device | Class II | 1 |
| 22 Nov 2016 | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated | Device | Class II | 1 |
| 15 Apr 2015 | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan | Drug | Class I | 7 |
| 10 Nov 2014 | Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (ND | Drug | Class III | 1 |
Official channels
- FDA enforcement report D-1517-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 74965. https://recallregister.com/fda/iii/74965/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
FL, MA and NJ
- What quantity of product is in FDA event 74965?
- The FDA record gives this quantity:
738 boxes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2016 have the same class?
- 43% of the 288 drug events that started in 2016 are in Class III.