Mucinex Fast-max Solution
FDA Recall NDC 63824-015
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 (NDC 63824-015). A significant event, classified as Class I, 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 I 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
495036 Bottles
Recall Profile & Regulatory Data
Event ID
71013
Classification
Class I
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 Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1
Batch or Lot Expiration Information
Lot# : Exp: MCF0048 7/31/2016 MCF0051 7/31/2016 MCF0052 8/31/2016 MCF0053 8/31/2016 MCF0054 8/31/2016 MCF0055 8/1/2016 MCF0056 8/31/2016 MCF0057 8/31/2016 MCF0058 8/31/2016 MCF0059 10/1/2016 MCF0060 8/31/2016 MCF0061 8/31/2016 MCF0062 8/31/2016 MCF0063 9/30/2016 MCF0064 9/30/2016 MCF0065 9/30/2016 MCF0066 9/30/2016 MCF0067 9/30/2016 MCF0068 9/30/2016 MCF0069 10/31/2016 MCF0070 10/31/2016 MCF0071 10/31/2016 MCF0072 10/31/2016 MCF0073 10/31/2016 MCF0074 10/31/2016 MCF0075 10/31/2016 MCF0076 10/31/2016 MCF0077 10/31/2016
Affected Packages Involved in this Recall
63824-015-66Product
63824-015-69Product
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.
