Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5
Check against the official notice below — it lists the full affected range.
Reckitt Benckiser LLC is recalling approximately 416,220 bottles of Mucinex Fast-Max DM Max liquid cough suppressant (6 fl oz) distributed nationwide. The bottles have a labeling error where the Drug Facts information on the back of the label is missing certain active ingredients, including acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. Because these ingredients are not listed, important safety warnings associated with them may also be missing from the label.
The recall affects bottles with specific lot numbers, including AA189 (expiring 1/31/2017) and lots MDM0036 through MDM0053 (with various expiration dates ranging from 9/30/2016 through 12/31/2016). The source document does not specify what consumers should do with affected bottles.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Nationwide Quantity: 416,220 Bottles Lot/code info: Lot # : Exp: AA189 1/31/2017 MDM0036 9/30/2016 MDM0039 11/30/2016 MDM0042 11/30/2016 MDM0043 11/30/2016 MDM0044 11/30/2016 MDM0045 11/30/2016 MDM0046 11/30/2016 MDM0047 11/30/2016 MDM0048 11/30/2016 MDM0049 12/31/2016 MDM0050 12/31/2016 MDM0052 12/31/2016 MDM0053 12/31/2016
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.