FDA Recall D-1366-2015

Reckitt Benckiser LLC · Parsippany, NJ

Class I — life-threatening Terminated 1059 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22

Lot / code: WO00726864 6/30/2016 WO00737979 1/31/2017 WO00740405 1/31/2017 WO00706571 7/31/2016 WO00707442 7/31/2016 WO00707443 7/31/2016 WO00707444 7/31/2016 WO00707822 7/31/2016 WO00709953 7/31/2016 WO00709955 6/30/2016 WO00720780 7/31/2016 WO00721052 7/31/2016 WO00721170 7/31/2016 WO00721171 7/31/2016 WO00726865 7/31/2016 WO00728864 7/31/2016 WO00728865 12/31/2016 WO00728866 12/31/2016 WO00730003 12/31/2016 WO00730004 12/31/2016 WO00735142 12/31/2016 WO00736753 12/31/2016 WO00737477 1/31/2017 WO00738556 12/31/2016 WO00739050 12/31/2016 WO00740406 1/31/2017

Quantity: 561,390 Bottles

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.

Recall record

Recall number: D-1366-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2015-04-15
Classified by FDA Center: 2015-08-25
FDA published: 2015-09-02
Terminated: 2018-03-09
Recalling firm: Reckitt Benckiser LLC
Firm location: Parsippany, NJ

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