Home / Recalls / Reckitt Benckiser LLC / D-1364-2015

D-1364-2015 Class I Terminated

Recalled by Reckitt Benckiser LLC — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
September 2, 2015
Initiation Date
April 15, 2015
Termination Date
March 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
717,336 Bottles

Product Description

Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, 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 63824-500-66, UPC 63824-50066-09

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

Lot #: Exp: MNT0003 7/31/2016 MNT0004 7/31/2016 MNT0005 7/31/2016 MNT0006 7/31/2016 MNT0007 7/31/2016 MNT0008 7/31/2016 MNT0009 7/31/2016 MNT0010 7/31/2016 MNT0011 7/31/2016 MNT0012 7/31/2016 MNT0013 7/31/2016 MNT0014 10/31/2016 MNT0015 10/31/2016 MNT0016 10/31/2016 MNT0017 10/31/2016 MNT0018 11/30/2016 MNT0019 11/30/2016 MNT0020 12/31/2016 MNT0021 12/31/2016 MNT0022 12/31/2016 MNT0023 12/31/2016 MNT0024 12/31/2016 MNT0025 12/31/2016 AA037 12/31/2017 AA060 1/31/2017 AA080 1/31/2017 AA097 1/31/2017

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  • Z-0091-2019 Class II — Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male c (August 6, 2018)
  • Z-3241-2018 Class II — Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-8 (July 23, 2018)
  • Z-1249-2017 Class II — Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubr (November 22, 2016)
  • D-1517-2016 Class III — Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, (August 3, 2016)
  • D-1369-2015 Class II — Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressan (April 15, 2015)
  • D-1368-2015 Class I — Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maxim (April 15, 2015)
  • D-1367-2015 Class I — Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan H (April 15, 2015)
  • D-1366-2015 Class I — Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - (April 15, 2015)