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Recall Observatory FDA recall evidence

Drug product

Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, 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 63824-015-66, UPC 63824-01565-1

D-1363-2015

April 15, 2015

Class I

Product summary

Firm
Reckitt Benckiser LLC
Event
Event 71013
Status
Terminated
Classification
Class I
Quantity
495036 Bottles
Official record key
drug-enforcement:D-1363-2015

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: MCF0048 7/31/2016 MCF0051 7/31/2016 MCF0052 8/31/2016 MCF0053 8/31/2016 MCF0054 8/31/2016 MCF0055 8/1/2016 MCF0056 8/31/2016 MCF0057 8/31/2016 MCF0058 8/31/2016 MCF0059 10/1/2016 MCF0060 8/31/2016 MCF0061 8/31/2016 MCF0062 8/31/2016 MCF0063 9/30/2016 MCF0064 9/30/2016 MCF0065 9/30/2016 MCF0066 9/30/2016 MCF0067 9/30/2016 MCF0068 9/30/2016 MCF0069 10/31/2016 MCF0070 10/31/2016 MCF0071 10/31/2016 MCF0072 10/31/2016 MCF0073 10/31/2016 MCF0074 10/31/2016 MCF0075 10/31/2016 MCF0076 10/31/2016 MCF0077 10/31/2016

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up