November 2014 FDA Recall Mucinex Dm by Reckitt Benckiser Llc
D-0964-2015 - Defective container
This Class III drug recall was voluntarily initiated by Reckitt Benckiser Llc on November 10, 2014 for the product Mucinex Dm. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0964-2015
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
11-10-2014
04-29-2015
155 cases (2000 pouches of 2 tablets per case)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Reckitt Benckiser LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
03-30-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
