Agency classClass IOur severity:Severe FDA (Drugs)·D-1365-2015·Announced 2015-09-02

Mucinex Fast-Max Cold & Sinus Recalled for Missing Drug Facts Labeling

Reckitt Benckiser is recalling Mucinex Fast-Max Cold & Sinus liquid because the back of the bottle is missing active ingredients and safety warnings.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum severity score of 4 (Severe).

Plain-English summary

Reckitt Benckiser LLC is recalling 379,284 bottles of Mucinex Fast-Max Cold & Sinus, Maximum Strength, 6 fl oz (180 mL) liquid. The product is distributed nationwide and is intended for ages 12 and older. The recall involves specific lot numbers with expiration dates ranging from July 31, 2016, to December 31, 2016.

The recall was initiated due to a labeling error. While the front of the bottle is correctly labeled, the back of the bottle, which contains the Drug Facts panel, is missing certain active ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. Consequently, specific safety warnings associated with these ingredients may also be missing from the label.

Consumers who have purchased this product should check the lot number and expiration date on the bottle. If the product matches the recalled lots, consumers should stop using it and contact Reckitt Benckiser for a refund or replacement.

The recalled product

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…
Manufacturer: Reckitt Benckiser LLC
Category: Drug — Over-the-Counter Medication
Hazard: mis-labeling
missing-safety-warnings
Affected units: 379,284

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Reckitt Benckiser LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Reckitt Benckiser LLC

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