Drug recall D-1369-2015
Product
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
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.
Lots and codes
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
Recall details
- Recalling firm
- Reckitt Benckiser LLC, Parsippany, NJ
- Quantity
- 416,220 Bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 15, 2015
- Terminated
- March 9, 2018
Related products
- Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu – drug information
- NDC 72854-165 Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu · · Reckitt Benckiser LLC
- NDC 63824-019 Mucinex Fast-Max DM Max · Dextromethorphan Hydrobromide 20 mg/20mL; Guaifenesin 400… · Reckitt Benckiser LLC