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Recall Observatory FDA recall evidence

Drug product

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

D-1368-2015

April 15, 2015

Class I

Product summary

Firm
Reckitt Benckiser LLC
Event
Event 71013
Status
Terminated
Classification
Class I
Quantity
561,390 Bottles
Official record key
drug-enforcement:D-1368-2015

Official wording

Reason: 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.

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

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up