Recalls / Class I

Class ID-1365-2015

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 & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, 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 63824-016-66, UPC 63824-01665-8

Affected lot / code info: Lot #: Exp: MCS0019 7/31/2016 MCS0020 7/31/2016 MCS0021 7/31/2016 MCS0022 8/31/2016 MCS0023 8/31/2016 MCS0024 9/30/2016 MCS0025 9/30/2016 MCS0026 9/30/2016 MCS0027 11/30/2016 MCS0028 10/31/2016 MCS0029 10/31/2016 MCS0030 12/31/2016 MCS0031 12/31/2016 MCS0032 12/31/2016 MCS0033 12/31/2016

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

Distribution

Quantity: 379,284 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-1365-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.