Reckitt Benckiser Mucinex Fast Max Severe Congestion & Cough 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.

Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4

Lot #: Exp: MSC0049 8/31/2016 MSC0050 8/31/2016 MSC0051 8/31/2016 MSC0052 8/31/2016 MSC0053 8/31/2016 MSC0054 8/31/2016 MSC0055 8/31/2016 MSC0056 9/30/2016 MSC0057 9/30/2016 MSC0058 9/30/2016 MSC0059 10/31/2016 MSC0060 10/31/2016 MSC0061 10/31/2016 MSC0062 10/31/2016 MSC0063 10/31/2016 MSC0064 10/31/2016 MSC0065 10/31/2016 MSC0066 10/30/2016 MSC0067 11/30/2016 MSC0068 11/30/2016 MSC0069 11/30/2016 MSC0070 11/30/2016 MSC0071 11/30/2016 MSC0073 11/30/2016 MSC0074 11/30/2016 MSC0075 11/30/2016 MSC0076 11/30/2016 MSC0077 12/31/2016 MSC0078 12/31/2016 MSC0079 12/31/2016 MSC0080 12/31/2016 MSC0082 12/31/2016

Nationwide

• Compare the lot number and expiration date on your package with the codes above.
• Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
• If you have symptoms you think are related, contact your doctor. In an emergency call 911.
• Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall number

D-1367-2015

Classification

Class I

Status

Terminated

Recall initiated

Apr 15, 2015

FDA report date

Sep 2, 2015

Quantity

200,688 Bottles

Recall type

Voluntary: Firm initiated

Recalling firm

Reckitt Benckiser LLC