Mucinex Fast-max Dm Max And Mucinex Nighttime Cold And Flu Kit
FDA Recall NDC 72854-165
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mucinex Fast-max Dm Max And Mucinex Nighttime Cold And Flu (NDC 72854-165). A significant event, classified as Class II, was initiated on Apr 15, 2015 by Reckitt Benckiser Llc. The reported reason for this action was: "Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Apr 15, 2015
Sep 02, 2015
416,220 Bottles
Recall Profile & Regulatory Data
Event ID
71013
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Reckitt Benckiser LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 09, 2018
Product Description
Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5
Batch or Lot Expiration Information
Lot# : Exp: AA189 1/31/2017 MDM0036 9/30/2016 MDM0039 11/30/2016 MDM0042 11/30/2016 MDM0043 11/30/2016 MDM0044 11/30/2016 MDM0045 11/30/2016 MDM0046 11/30/2016 MDM0047 11/30/2016 MDM0048 11/30/2016 MDM0049 12/31/2016 MDM0050 12/31/2016 MDM0052 12/31/2016 MDM0053 12/31/2016
Affected Packages Involved in this Recall
72854-165-26Product
63824-503-66Product
63824-019-66Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
