FDA Recall D-1365-2015

Reckitt Benckiser LLC · Parsippany, NJ

Class I — life-threatening Terminated 1059 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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

Lot / code: 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

Quantity: 379,284 Bottles

Reason for recall

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.

Recall record

Recall number: D-1365-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2015-04-15
Classified by FDA Center: 2015-08-25
FDA published: 2015-09-02
Terminated: 2018-03-09
Recalling firm: Reckitt Benckiser LLC
Firm location: Parsippany, NJ

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