US Drug Recall Register
Class I · High risk Terminated Initiated Apr 15, 2015 (11 years ago)

Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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.

What was recalled

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

Recalling firm
Reckitt Benckiser LLC
NDC code
63824-528-22
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1368-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.