FDAFDA · Food and drugs·Recall number D-1364-2015
Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, 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 63824-500-66, UPC 63824-50066-09
Published September 2, 2015 · Recall initiated: April 15, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Reckitt Benckiser LLC
- Distributor
- Nationwide
- Lot
- Lot #: Exp: MNT0003 7/31/2016 MNT0004 7/31/2016 MNT0005 7/31/2016 MNT0006 7/31/2016 MNT0007 7/31/2016 MNT0008 7/31/2016 MNT0009 7/31/2016 MNT0010 7/31/2016 MNT0011 7/31/2016 MNT0012 7/31/2016 MNT0013 7/31/2016 MNT0014 10/31/2016 MNT0015 10/31/2016 MNT0016 10/31/2016 MNT0017 10/31/2016 MNT0018 11/30/2016 MNT0019 11/30/2016 MNT0020 12/31/2016 MNT0021 12/31/2016 MNT0022 12/31/2016 MNT0023 12/31/2016 MNT0024 12/31/2016 MNT0025 12/31/2016 AA037 12/31/2017 AA060 1/31/2017 AA080 1/31/2017 AA097 1/31/2017
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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