Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reduc...

FDA Drug Recall #D-1364-2015 — Class I — April 15, 2015

Recall Summary

Recall Number D-1364-2015
Classification Class I — Serious risk
Date Initiated April 15, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Reckitt Benckiser LLC
Location Parsippany, NJ
Product Type Drugs
Quantity 717,336 Bottles

Product Description

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

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.

Distribution Pattern

Nationwide

Lot / Code Information

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

Other Recalls from Reckitt Benckiser LLC

Recall # Classification Product Date
D-1517-2016 Class III Mucinex Sinus-Max Day Night, 60 caplets, Dist. ... Aug 3, 2016
D-1363-2015 Class I Mucinex Fast Max Cold, Flu & Sore Throat, Maxim... Apr 15, 2015
D-1365-2015 Class I Mucinex Fast-Max Cold & Sinus, Maximum Strength... Apr 15, 2015
D-1367-2015 Class I Mucinex Fast Max Severe Congestion & Cough, Max... Apr 15, 2015
D-1368-2015 Class I Mucinex Fast Max Day Time Severe Congestion & C... Apr 15, 2015

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.