FDA-Drug2015-04-29Class III

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

Reckitt Benckiser LLC
Hazard

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

Sold states
Nationwide
Affected count
155 cases (2000 pouches of 2 tablets per case)
Manufactured in
399 Interpace Pkwy, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0964-2015

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