Reckitt Benckiser LLC recalls Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expect
Recalled September 2, 2015 · FDA recall D-1367-2015 · Reckitt Benckiser
Hazard
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. · FDA Class I
Units
200,688 Bottles
Sold at
Nationwide
Description
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.
Product
Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4
Manufacturer(s)
Reckitt Benckiser LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →