Mucinex Dm Tablet, Extended Release
FDA Recall NDC 63824-056
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 Dm (NDC 63824-056). A significant event, classified as Class III, was initiated on Nov 10, 2014 by Reckitt Benckiser Llc. The reported reason for this action was: "Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch"
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 III Terminated
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Nov 10, 2014
Apr 29, 2015
155 cases (2000 pouches of 2 tablets per case)
Recall Profile & Regulatory Data
Event ID
70840
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Reckitt Benckiser LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 30, 2018
Product Description
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England
Batch or Lot Expiration Information
Lot# Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016
Affected Packages Involved in this Recall
63824-056-89Product
63824-056-36Product
63824-056-32Product
63824-056-34Product
63824-056-69Product
63824-056-73Product
63824-056-74Product
63824-056-72Product
63824-056-11Product
63824-056-01Product
63824-056-50Product
63824-056-80Product
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.
