Recalls / Class I

Class ID-1366-2015

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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

Affected lot / code info: 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

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.

Recalling firm

Firm: Reckitt Benckiser LLC
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 399 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1133

Distribution

Quantity: 561,390 Bottles
Distribution pattern: Nationwide

Timeline

Recall initiated: 2015-04-15
FDA classified: 2015-08-25
Posted by FDA: 2015-09-02
Terminated: 2018-03-09
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1366-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.