Recalls / Class III
Class IIID-0964-2015
Product
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England
- Brand name
- Mucinex Dm
- Generic name
- Guaifenesin And Dextromethorphan Hydrobromide
- Active ingredients
- Dextromethorphan Hydrobromide, Guaifenesin
- Route
- Oral
- NDC
- 63824-056
- FDA application
- NDA021620
- Affected lot / code info
- Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016
Why it was recalled
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Recalling firm
- Firm
- Reckitt Benckiser LLC
- Manufacturer
- RB Health (US) LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 399 Interpace Pkwy, Parsippany, New Jersey 07054-1133
Distribution
- Quantity
- 155 cases (2000 pouches of 2 tablets per case)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-11-10
- FDA classified
- 2015-04-21
- Posted by FDA
- 2015-04-29
- Terminated
- 2018-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0964-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.