Home / Recalls / Reckitt Benckiser LLC / D-1369-2015

D-1369-2015 Class II 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
416,220 Bottles

Product Description

Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5

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: AA189 1/31/2017 MDM0036 9/30/2016 MDM0039 11/30/2016 MDM0042 11/30/2016 MDM0043 11/30/2016 MDM0044 11/30/2016 MDM0045 11/30/2016 MDM0046 11/30/2016 MDM0047 11/30/2016 MDM0048 11/30/2016 MDM0049 12/31/2016 MDM0050 12/31/2016 MDM0052 12/31/2016 MDM0053 12/31/2016

Other recalls by Reckitt Benckiser LLC

  • 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-1363-2015 Class I — Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain R (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)