Home / Recalls / Reckitt Benckiser LLC / D-1368-2015

D-1368-2015 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
561,390 Bottles

Product Description

Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9

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: WO00707825 5/31/2016 WO00713226 7/31/2016 WO00715310 6/30/2016 WO00715505 7/31/2016 WO00721174 9/30/2016 WO00721177 10/31/2016 WO00726860 10/31/2016 WO00726862 6/30/2016 WO00726952 8/31/2016 WO00728861 6/30/2016 WO00728878 7/31/2016 WO00728879 9/30/2016

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  • Z-0993-2019 Class II — Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89 (December 19, 2018)
  • Z-0994-2019 Class II — Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729- (December 19, 2018)
  • 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-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)
  • D-1364-2015 Class I — Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Rel (April 15, 2015)