Recalls / Class I

Class ID-1363-2015

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 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

Brand name: Mucinex Fast-max
Generic name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Active ingredients: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Route: Oral
NDC: 63824-015
FDA application: M012
Affected lot / code info: 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

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
Manufacturer: RB Health (US) LLC
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 399 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1133

Distribution

Quantity: 495036 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-1363-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.