Recalls / Class II
Class IID-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
- Brand name
- Mucinex Fast-max Dm Max And Mucinex Nighttime Cold And Flu
- Generic name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Triprolidine Hydrochloride
- NDC
- 72854-165
- FDA application
- M012
- Affected 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
Why it was recalled
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.
Recalling firm
- Firm
- Reckitt Benckiser LLC
- Manufacturer
- RB Health (US) LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 399 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1133
Distribution
- Quantity
- 416,220 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-15
- FDA classified
- 2015-08-25
- Posted by FDA
- 2015-09-02
- Terminated
- 2018-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1369-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.